53675-192-02
53675-193-08
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
75% Alcohol Shierjie
43116-001-01
43116-001-02
43116-001-03
43116-001-04
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
75% Alcohol rinse free hand sanitizer Shierjie
43116-002-01
43116-002-02
43116-002-03
43116-002-04
43116-002-05
43116-002-06
43116-002-07
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Shierjie Medical Alcohol Wipes
43116-003-01
43116-003-02
43116-003-03
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Shierjie 75% Alcohol Wipes
43116-020-01
43116-020-02
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Shierjie Disinfecting Soft Wipes
43116-026-01
43116-026-02
43116-026-03
43116-026-04
43116-026-05
43116-026-06
43116-026-07
43116-026-08
43116-026-09
43116-026-10
43116-026-11
43116-026-12
43116-026-13
43116-026-14
43116-026-15
43116-027-02
43116-004-02
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Salusen Premium 75% Alcohol Disinfectant Wipes
43116-006-01
43116-006-02
43116-006-03
43116-006-04
Procom Products Inc. (California)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Alcohol pads One pad saturated with 75% alcohol
43116-016-01
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
WBM Care Natural Aloe Advanced Hand Sanitizer
43116-007-01
WBM USA (New Jersey)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
WBM Care Advanced Hand Sanitizer Natural Aloe
43116-008-01
43116-008-02
WBM USA (New Jersey)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
WBM Care Advanced Hand Sanitizer Lemon & Orange
43116-009-01
WBM USA (New Jersey)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
XEPA Antibacterial Hand Wipes
43116-010-01
Apex Enterprise Inc. (California)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
75% Alcohol Hand Sanitizer Gel
43116-015-01
43116-015-02
43116-015-03
43116-015-04
43116-015-05
43116-015-06
43116-015-07
43116-015-08
43116-015-09
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Shierjie Alcohol Wipes
43116-018-01
43116-018-02
43116-018-03
43116-018-04
43116-018-05
43116-018-06
43116-018-07
43116-018-08
43116-018-09
43116-018-10
43116-018-11
43116-018-12
43116-018-13
43116-018-14
43116-018-15
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
75% Alcohol Antibacterial Hand Wipes
43116-021-02
Grocery Outlet Inc. (California)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Necessities Antibacterial Wipes Aloe Vera
43116-021-01
PK Douglass (Canada)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
XS Alcohol Prep Pad
43116-022-01
43116-023-01
80015-434-01
XS-Supply (Florida)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
XS Wipes 75% Alcohol Wipes
43116-025-01
XS-Supply (Florida)
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Alcohol Antiseptic Hand Sanitizer Antibacterial
43116-030-01
Custom Quest (Ohio)
02/21/2024
02/21/2024
Jiangsu Hanhe Daily Chemicals Co., Ltd. (China)
Kentex Instant Hand Sanitizer with Aloe Vera
69556-333-02
69556-333-08
69556-333-16
69556-333-32
Kentron Healthcare, Inc. (Tennessee)
Product manufactured at a facility that did not respond to multiple notice of inspection requests from FDA related to drug manufacturing and product quality.
01/10/2024
Jiangsu Hanhe Daily Chemicals Co., Ltd. (China)
Kentex Hand Sanitizing Wet Wipes
69556-444-80
Kentron Healthcare, Inc. (Tennessee)
Product manufactured at a facility that did not respond to multiple notice of inspection requests from FDA related to drug manufacturing and product quality.
01/10/2024
Jiangsu Hanhe Daily Chemicals Co., Ltd. (China)
Medical Mary Clean Hand Gel Sanitizer
73027-101-06
73027-101-12
73027-101-30
73027-101-50
Medical Mary, LLC (Michigan)
Product manufactured at a facility that did not respond to multiple notice of inspection requests from FDA related to drug manufacturing and product quality.
01/10/2024
Jiangsu Hanhe Daily Chemicals Co., Ltd. (China)
Fresh Basics + Disinfectant Gel
73027-106-01
73027-106-02
80550-002-01
80550-002-02
3B International LLC
Product manufactured at a facility that did not respond to multiple notice of inspection requests from FDA related to drug manufacturing and product quality.
01/10/2024
Hygienic Labs, LLC.
(Iowa)
KleenSwell Liquid Hand Sanitizer
79692-002-01
79692-002-05
79692-002-50
Hygienic Labs, LLC.
(Iowa)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued warning letter on 9/19/2023.
11/08/2023
Hygienic Labs, LLC.
(Iowa)
KleenSwell Gel Hand Sanitizer with Aloe
79692-003-01
79692-003-08
79692-003-05
79692-003-16
79692-003-50
Hygienic Labs, LLC.
(Iowa)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued warning letter on 9/19/2023.
11/08//2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Extra Soft Advanced Formula Hand Sanitizer
74955-020-17
74955-020-18
74955-020-33
74955-020-84
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Soft & Gentle Antibacterial Wet Wipes
74955-021-01
74955-021-02
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Hand Cleaning Spray Antibacterial Hand Sanitizer
74955-022-05
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Alcohol Wipes Containing 70% Antibacterial Plus Hygiene
74955-027-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Extra Soft Antibacterial Wipes with Alcohol
74955-028-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Extra Soft Multipurpose Sanitizing Wipes
74955-029-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Extra Soft 75% Alcohol Sanitizing Spray Berry Fresh Scent
74955-034-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Extra Soft 75% Alcohol Sanitizing Spray Citrus Fresh Scent
74955-035-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Extra Soft 75% Alcohol Sanitizing Spray Crisp Linen Fresh
74955-036-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Extra Soft 75% Alcohol Sanitizing Spray Ocean Fresh Scent
74955-037-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Natural Sense 75% Alcohol Wipes Lemon Scent
74955-038-02
78440-002-01
78440-002-02
78440-002-03
IGT Group (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Quick Protect Sanitizing Spray Linen Fresh
74955-039-02
80702-039-02
Premier Wholesale (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Naturally Antibacterial Wet Wipes Formulated to Include Aloe Vera
74955-040-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Health Smart Instant Hand Sanitizer with Aloe Vera & Vitamin E Original
52862-606-08
Homesmart Products (Michigan)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Health Smart Instant Hand Sanitizer with Aloe Vera & Vitamin E Cucumber Melon
52862-607-08
Homesmart Products (Michigan)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Health Smart Instant Hand Sanitizer with Aloe Vera & Vitamin E Sweet Pea
52862-608-08
Homesmart Products (Michigan)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Health Smart Instant Hand Sanitizer with Aloe Vera & Vitamin E Lavender
52862-609-08
Homesmart Products (Michigan)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Health Smart Instant Hand Sanitizer with Aloe Vera & Vitamin E Peach
52862-610-08
Homesmart Products (Michigan)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Health Smart Wet Wipes Antibacterial for Hands & Face
52862-611-10
52862-611-30
52862-611-40
52862-611-50
52862-611-00
52862-613-01
52862-613-02
78564-613-01
78564-613-02
Homesmart Products (Michigan)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Germ Out Fresh Scent Antibacterial Wet Wipes
72308-015-20
72308-015-60
72308-025-20
72308-025-60
Flex Beauty Labs, LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Visibly Clean Antibacterial Wet Wipes Blue Sage Lime
72308-036-00
Flex Beauty Labs, LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Visibly Clean Antibacterial Wet Wipes Strawberry Tart
72308-037-00
Flex Beauty Labs, LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Visibly Clean Antibacterial Wet Wipes Fresh Lemonade
72308-038-00
Flex Beauty Labs, LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Bittol Anti-Bacterial Wet Wipes
78564-000-01
78564-000-02
78564-000-03
78564-000-04
78564-000-05
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Bittol Anti-Bacterial Hand Gel
78564-001-01
78564-001-02
78564-001-03
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Bittol Anti-Bacterial Hygienic Hand Cleaning Liquid
78564-003-01
78564-003-02
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Bittol Alcohol Wipes
78564-004-01
78564-004-02
78564-004-03
78564-004-04
78564-004-05
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Ten Wet Wipes Antibacterial for Hands & Face
78564-006-10
COSCA Inc (Puerto Rico)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Antibacterial Colmerg Hand Sanitizing Wipes
80171-001-00
80171-002-00
Colmerg Products LLC (New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Gulf States International, Inc.
(Alabama)
Brittanie’s Thyme Rosemary and Peppermint Hand Sanitizer
76473-100-01
Brittanie’s Thyme, LLC (Alabama)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 09/12/2023.
11/01/2023
Gulf States International, Inc.
(Alabama)
Brittanie’s Thyme Orange and Peppermint Hand Sanitizer
76473-101-01
Brittanie’s Thyme, LLC (Alabama)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 09/12/2023.
11/01/2023
Gulf States International, Inc.
(Alabama)
Brittanie’s Thyme Lemongrass and Peppermint Hand Sanitizer
76473-102-01
Brittanie’s Thyme, LLC (Alabama)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 09/12/2023.
11/01/2023
Gulf States International, Inc.
(Alabama)
Brittanie’s Thyme Lavender and Peppermint Hand Sanitizer
76473-103-01
Brittanie’s Thyme, LLC (Alabama)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 09/12/2023.
11/01/2023
Gulf States International, Inc.
(Alabama)
Brittanie’s Thyme Gel Hand Sanitizer
76473-104-01
Brittanie’s Thyme, LLC (Alabama)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 09/12/2023.
11/01/2023
Maison Blanche LLC (Texas)
Hand Sanitizer N°93 Maison Blanche Eucalyptus & Coconut Oil
78966-111-11
78966-111-12
78966-111-13
Maison Blanche LLC (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 09/14/2023.
10/11/2023
WIPRO Consumer Care Vietnam Co. Ltd. (Vietnam)
Aiken Hand Sanitizer
75651-172-01
75651-172-02
75651-172-22
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Sukhtian Households and Toiletries Manufacturing Co. Ltd. (Jordan)
HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads
71490-001-02
71490-001-03
71490-002-02
71490-002-03
71490-003-02
71490-003-03
71490-004-02
71490-004-03
71490-005-02
71490-005-03
71490-006-02
71490-006-03
71490-007-02
71490-007-03
71490-008-02
71490-008-03
71490-009-02
71490-009-03
71490-010-02
71490-010-03
71490-011-02
71490-011-03
71490-012-02
71490-012-03
71490-013-02
71490-013-03
71490-014-02
71490-014-03
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Sukhtian Households and Toiletries Manufacturing Co. Ltd. (Jordan)
HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads
71490-015-03
71490-016-03
71490-017-03
71490-018-03
71490-019-03
71490-020-03
71490-021-03
71490-022-03
71490-023-03
71490-024-03
71490-025-03
71490-026-03
71490-027-03
71490-028-03
71490-030-03
71490-031-05
71490-032-03
71490-032-05
71490-033-03
71490-033-05
71490-034-03
71490-034-05
71490-035-03
71490-035-05
71490-036-05
71490-037-03
71490-037-05
71490-038-05
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Sukhtian Households and Toiletries Manufacturing Co. Ltd. (Jordan)
HiGeen Gold Antiseptic Hand Sanitizer Gel with Vitamin Beads
71490-029-03
71490-030-03
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Sukhtian Households and Toiletries Manufacturing Co. Ltd. (Jordan)
HiGeen Antiseptic Hand Sanitizer Gel
71490-039-01
71490-039-07
71490-040-01
71490-040-07
71490-041-01
71490-041-04
71490-041-07
71490-042-04
71490-059-01
71490-059-07
71490-059-08
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Sukhtian Households and Toiletries Manufacturing Co. Ltd. (Jordan)
HiGeen Antiseptic Hands & Things Sanitizer Spray
71490-043-08
71490-043-09
71490-043-13
71490-044-09
71490-045-08
71490-045-09
71490-045-13
71490-046-08
71490-046-09
71490-046-13
71490-047-08
71490-047-09
71490-047-13
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
GTP International Corp. (Texas)
Green Beauty Advanced Hand Sanitizer
79347-000-01
Unknown
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 08/30/2023.
08/30/2023
Cergomex Imports, LLC (Texas)
Sanetto Hands Sanitizer Gel
81101-200-02
81101-200-03
81101-200-04
Cergomex Imports, LLC (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a warning letter on 08/04/2023.
08/30/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
First Safety Instant Hand Sanitizer Wipes (70% Alcohol)
74763-002-01
74763-002-02
74763-002-03
74763-002-04
76720-002-01
76720-002-02
76720-002-03
76720-002-04
76720-002-05
76720-002-06
First Safety (Massachusetts)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
Responsible Hand Sanitizer Advanced Moisturizing Formula With Vitamin E
(70% Alcohol)
74763-003-01
74763-003-02
74763-003-03
76720-003-01
76720-003-02
76720-003-03
Clover Imaging Group (Illinois)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
OmegaClean Alcohol Wipes
74763-005-01
74763-005-02
74763-005-03
JAS Supply (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
First Safety Instant Hand Sanitizer Wipes (75% Alcohol)
74763-013-01
74763-013-02
76720-013-01
76720-013-02
76720-013-03
76720-013-04
76720-013-05
First Safety (Massachusetts)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
AltruFuel Sanitizer Wipes (75% Alcohol)
74763-014-01
74763-015-01
75421-002-00
75421-002-01
75421-002-02
Altrufuel dba Mad Dog Concepts, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
Miami Carry On Disinfecting & Sanitizing 75% Alcohol Wipes
74763-018-01
74763-018-02
74763-018-03
74763-018-04
74763-018-05
Naftali Inc. (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
M Antibacterial Hand Gel Packs
74763-019-01
74763-019-11
Mytagalongs (Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
DefendMax Hand Sanitizer (75% Alcohol)
78256-102-01
78256-102-02
78256-102-08
78256-102-16
78256-102-32
78256-102-64
DefendMax (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
PuraHands Hand Sanitizer
78256-104-02
78256-104-08
78256-104-16
PuraHands (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
Miami Carry On Instant Hand Sanitizer With Vitamin E
74763-012-01
74763-012-02
74763-012-03
74763-012-04
Naftali Inc. (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
Gafle Hand Sanitizer Gel with moisturizer
74763-001-01
74763-001-02
74763-001-03
74763-001-04
74763-001-05
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Yesililgaz Kozmetik Kimya Insaat Otomotiv Ve Gida Sanayi
(Turkey)
ALLPURE Hand Sanitizer with Soothing Aloe Vera Natural 70% Alcohol
78575-002-01
78575-002-02
78575-002-03
78575-002-04
78575-002-05
78575-002-06
78575-002-07
CERCI USA Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
08/23/2023
Yesililgaz Kozmetik Kimya Insaat Otomotiv Ve Gida Sanayi
(Turkey)
DEVANIT Hand Sanitizer Natural 70% Alcohol Antiseptic with Soothing Aloe Vera
78575-001-01
78575-001-02
78575-001-03
78575-001-04
78575-001-05
78575-001-06
CERCI USA Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
08/23/2023
Planet Luxe Operations Pty, Ltd.
(Australia)
Planet Luxe Hand Sanitizer
81109-000-50
81109-001-50
Planet Luxe Operations Pty, Ltd. (Australia)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
08/23/2023
Absolut Distillers, Ltd.
(Philippines)
ALCOGENIX Alcohol
Antiseptic 80% Topical Solution Hand Sanitizer
90046-503-01
90047-503-01
Midway Trading Corporation (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
08/23/2023
Leads China Biotech Co., Ltd.
(China)
Myxx Antibacterial Hand Sanitizer
72619-2020-1
72619-2020-2
72619-2020-4
77969-004-01
77969-004-02
Accessory Myxx LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to Import alert to help stop their products from entering the U.S. on 09/14/2023.
08/23/2023
Leads China Biotech Co., Ltd.
(China)
Hand Sanitizer Contains 70% Ethyl Alcohol Topical Solution
75624-123-01
75624-123-02
75624-123-03
75624-123-04
75624-123-05
75624-123-06
SCAASIS/Oceanic Trading (New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/14/2023.
08/23/2023
Leads China Biotech Co., Ltd.
(China)
Lovemee Hand Sanitizer
77969-001-01
77969-001-02
77969-001-04
77969-001-05
77969-001-06
77969-001-07
77969-001-08
77969-001-09
Unknown
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Leads China Biotech Co., Ltd.
(China)
Doc Hygiene Hand Sanitizer Spray
77969-003-01
Doc Hygiene
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Leads China Biotech Co., Ltd.
(China)
Doc Hygiene Hand Sanitizer Extra Strength
77969-002-01
77969-002-02
78765-001-01
79508-010-01
79508-010-02
79508-010-03
Doc Hygiene
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
Antibacterial Hand Wipes
(75% Alcohol)
77765-000-01
77765-000-02
77765-000-03
79188-000-01
79188-000-02
79188-000-03
Sam Hedaya Corp. (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
Pura Wipes (75% Alcohol)
77765-001-00
79300-001-00
Zaappaaz LLC (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
XcellaClean 75% Alcohol Disinfectant Wipes
77765-012-01
77765-012-02
77765-012-03
77765-012-04
77765-012-05
77765-012-06
77765-012-07
77765-012-08
77765-012-09
77765-012-10
77765-012-11
77765-012-12
77765-012-13
77765-012-14
77765-012-15
77765-012-16
77765-012-17
77765-012-18
Ningbo Unice Houseware Co., Ltd (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
XcellaClean Mild antibacterial formula Disinfectant Wipes
77765-013-01
77765-013-02
77765-013-03
77765-013-04
77765-013-05
77765-013-06
77765-013-07
77765-013-08
77765-013-09
77765-013-10
77765-013-11
77765-013-12
77765-013-13
77765-013-14
77765-013-15
77765-013-16
77765-013-17
77765-013-18
Ningbo Unice Houseware Co., Ltd (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
DailyGard Wipes Ethyl Alcohol 75%
77765-014-01
OlleyMay (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
DailyGard Wet Wipes
77765-015-01
Carity USA LLC (Delaware)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
DailyGard Wipes Ethyl Alcohol 75%
77765-011-01
77765-011-02
77765-011-03
77765-011-04
77765-011-05
77765-011-06
77765-011-07
77765-011-08
77765-011-10
77765-021-01
77765-021-02
77765-021-03
77765-021-04
77765-021-05
77765-021-06
77765-021-07
77765-021-08
77765-021-09
77765-021-10
Candy Brush LLC (Nevada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
DailyGard Wipes 75% Ethyl Alcohol
78198-004-01
78198-004-02
Creative Home Ideas (New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
DailyGard Wipes 75% Isopropyl Alcohol
78198-005-01
78198-005-02
Creative Home Ideas (New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Amata Life Plus Co., Ltd.
(Thailand)
Clean Day Antiseptic
(70% Alcohol)
80167-070-01
Unknown
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/31/2023.
08/16/2023
Prenger Furniture Inc.
(Iowa)
PFI Hand Sanitizer 80% Alcohol
74667-001-01
Unknown
FDA tested product; contains unacceptable level of acetal and acetaldehyde contaminants; Product manufactured at a facility that did not respond to multiple FDA requests for information related to drug manufacturing, product quality, and the scope of the contamination.
08/02/2023
Farmacos Bioequivalentes, S.A., dba: Biopharma
(Nicaragua)
Gelim Alcohol Antiseptic Topical Gel 80% Hand Sanitizer
79492-000-01
In & Out Products & Services (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
08/02/2023
Farmacos Bioequivalentes, S.A., dba: Biopharma
(Nicaragua)
Gelim Alcohol Antiseptic Topical Gel 80% Hand Sanitizer
79492-000-02
79492-000-03
79492-000-04
79492-000-05
79492-000-06
79492-000-07
Unknown
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
08/02/2023
Farmacos Bioequivalentes, S.A., dba: Biopharma
(Nicaragua)
Ethyl 80% Alcohol Solution (Ethyl Alcohol 80%)
79492-001-01
Unknown
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality
08/02/2023
Farmacos Bioequivalentes, S.A., dba: Biopharma
(Nicaragua)
Isopropyl Alcohol (ANTI-INFECTIVE, TOPICAL) Hand Sanitizer
Unable to determine
Unknown
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
08/02/2023
Penseur Kreativa Group
(Dominican Republic)
CARE HAND
Antibacterial
Desinfectante De Manos (Isopropyl Alcohol 70%)
81227-000-01
81227-000-02
81227-000-03
81227-000-04
81227-000-05
81227-000-06
81227-000-07
81227-000-08
81227-000-09
Penseur Kreativa Group
(Dominican Republic)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Penseur Kreativa Group
(Dominican Republic)
PENSEUR GROUP
Alcohol Isopropilico (Isopropyl Alcohol 70%)
81227-002-00
81227-002-01
81227-002-02
81227-002-03
81227-002-04
Penseur Kreativa Group
(Dominican Republic)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Penseur Kreativa Group
(Dominican Republic)
GO GERMS OUT
Antiseptic (Isopropyl Alcohol 70%)
81227-001-00
81227-001-01
81227-001-02
81227-001-03
81227-004-00
81227-004-01
81227-004-02
81227-004-03
81227-004-04
Penseur
Products Group LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Penseur Kreativa Group
(Dominican Republic)
VPBIOMED Antiseptic
Hand Sanitizer (Isopropyl Alcohol 70%)
81227-008-00
81227-008-01
81227-008-02
81227-008-03
81227-009-00
81227-009-01
81227-009-02
81227-010-00
81227-010-02
81227-010-02
Paola Enterprises para
VP Biomed LLC (Puerto Rico)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
(Canada)
Beattie’s Distillers Hand Sanitizer
77427-7427-7
Beattie’s Distillers Inc
(Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
06/21/2023
Beattie’s Distillers Inc
(Canada)
Beattie’s Distillers Hand Sanitizer Liquid 80% Alcohol
77427-7444-4
Beattie’s Distillers Inc
(Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
06/21/2023
Beattie’s Distillers Inc
(Canada)
Beattie’s Distillers Hand Sanitizer Gel Formula
77427-6311-5
Beattie’s Distillers Inc
(Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
06/21/2023
Classic Wine Vinegar Company, Inc.
(California)
Absolved Hand Sanitizer
75600-807-01
75600-807-04
75600-807-10
75600-807-12
75600-807-25
75600-807-27
75600-807-55
Not listed
FDA tested product; contains unacceptable level of acetal contaminant; Product manufactured at a facility that did not respond to multiple FDA requests for information related to drug manufacturing, product quality, and the scope of the contamination
06/21/2023
Classic Wine Vinegar Company, Inc.
(California)
Absolved Hand Sanitizer
75600-807-50
Entral Product Solutions (California)
Product purported to be made at the same facility that produced an acetal contaminated product; Product manufactured at a facility that did not respond to multiple FDA requests for information related to drug manufacturing, product quality, and the scope of the contamination
06/21/2023
Classic Wine Vinegar Company, Inc.
(California)
Hand Sanitizer Liquid
79117-070-01
79117-070-55
79117-070-99
Emerge Technologies, Inc. (Texas)
Product purported to be made at the same facility that produced an acetal contaminated product; Product manufactured at a facility that did not respond to multiple FDA requests for information related to drug manufacturing, product quality, and the scope of the contamination
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Sierra Soft Alcohol hand sanitizer
70415-002-01
70415-100-01
76591-109-01
Sierra Health Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Royal 70% Alcohol Foam Hand Sanitizer
70415-202-01
76591-108-01
Royal Papers, Inc.
(Missouri)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Fresh Hand Foaming Hand Sanitizer Alcohol Foam
70415-203-11
76591-104-11
Resource Solutions of SF Group, Inc (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Hand Hygiene Puro 70% Alcohol Foaming Hand Sanitizer
70415-402-01
76591-105-01
Sierra Health, Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Delicare Alcohol Hand Sanitizer
70415-601-11
76591-103-11
76591-106-11
SML Medical Supplies, Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
HYTN Hand Sanitizer with Aloe Vera Extract Vitamin E & Moisturizer
74871-052-00
74871-052-01
74871-062-00
74871-062-01
74871-101-00
74871-101-01
74871-238-00
74871-238-01
74871-501-00
74871-902-00
iTech361 LLC (New Mexico)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
PPE 361 Hand Sanitizer with Aloe Vera Extract Vitamin E & Moisturizer
74871-053-00
74871-063-00
74871-102-00
74871-239-00
74871-502-00
74871-903-00
76591-102-01
76591-102-02
76591-102-03
76591-102-04
76591-102-05
76591-102-06
iTech361 LLC (New Mexico)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
HYTN 75% Alcohol Multipurpose Wipes
74871-081-00
iTech361 LLC (New Mexico)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Raw Instant Hand Sanitizer Gel
75353-614-50
The Raw Office Inc. (Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Altrufuel advanced formula With Aloe Vera Hand Sanitizer
75421-000-00
75421-000-01
Mad Dog Concepts, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Altrufuel advanced formula With Vitamin E + Aloe Vera Hand Sanitizer
75421-001-00
75421-001-01
Mad Dog Concepts, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Physicians Wellness Products Hand Sanitizer Alcohol Antispetic 75%
76591-001-01
76591-001-02
79242-001-01
79242-001-02
Physician’s Wellness Group Inc (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Gotdya Bacteriostatic Rate 99.9% Disposable Alcohol Rinse-free Hand Sanitizer
76591-101-01
76591-101-02
76591-101-03
76591-101-04
76591-101-05
76591-101-06
76591-101-07
76591-101-08
76591-101-09
76591-101-10
76591-101-11
76591-101-12
76591-101-13
76591-101-14
76591-101-15
76591-101-16
76591-101-17
76591-101-18
76591-101-19
76591-101-20
76591-101-21
76591-101-22
76591-101-23
76591-101-24
76591-101-25
76591-101-26
76591-101-27
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Gotdya Bacteriostatic Rate 99.9% Disposable Alcohol Sanitizer
76591-201-01
76591-201-02
76591-201-03
76591-201-04
76591-201-05
76591-201-06
76591-201-07
76591-201-08
76591-201-09
76591-201-10
76591-201-11
76591-201-12
76591-201-13
76591-201-14
76591-201-15
76591-201-16
76591-201-17
76591-201-18
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Gotdya Bacteriostatic Rate 99.9% Disposable Alcohol Sanitizer
76591-301-01
76591-301-02
76591-301-03
76591-301-04
76591-301-05
76591-301-06
76591-301-07
76591-301-08
76591-301-09
76591-301-10
76591-301-11
76591-301-12
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Gotdya Bacteriostatic Rate 99.99% Gel Alcohol Hand Sanitizer
76591-401-01
76591-401-02
76591-401-03
76591-401-04
76591-401-05
76591-401-06
76591-401-07
76591-401-08
Guangzhou Gotdya Fine Chemical Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Halloween Party Favors Hand Sanitizer
76591-402-01
Walmart Inc. (Arkansas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Gotdya Bacteriostatic Rate 99.99% Spray Alcohol Hand Sanitizer
76591-501-01
76591-501-02
76591-501-03
76591-501-04
Guangzhou Gotdya Fine Chemical Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Gotdya Bacteriostatic Rate 99.99% Disposable Alcohol 75% Alcohol Antiseptic Wipes
76591-601-01
76591-601-02
76591-601-03
76591-601-04
Guangzhou Gotdya Fine Chemical Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
CenterWell Bacteriostatic Rate 99.9% Spray Alcohol Hand Sanitizer
76591-701-01
Guangzhou Gotdya Fine Chemical Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Maxda Care Alcohol Gel Hand Sanitizer
76591-801-01
Vertriebs GmbH (Germany)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
LIFEMEDZ Hand Sanitizer
78500-100-30
LIFEMEDZ LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
LIFEMEDZ Rinse-Free Hand Sanitizer
78500-101-30
78500-101-38
78500-101-50
LIFEMEDZ LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Miracle Brands Touchless Dispenser Hand Sanitizer
80352-001-01
Miracle Brands, LLC (Arizona)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Miracle Brands Hand Sanitizer Refill Bottle
80352-002-01
Miracle Brands, LLC (Arizona)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Sanibeads Hand Sanitizer Filled Bracelet
80627-001-01
Sanibeads, LLC (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Tego Systems Professional Grade Hand Sanitizer
81497-700-01
81497-701-01
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
IBC Business COOP
(South Korea)
Young Living Thieves Waterless Hand Sanitizer
70631-577-03
70631-577-30
70631-577-47
70631-577-60
70631-577-76
82128-001-22
82128-001-29
Young Living Essential Oils, LC. (Utah)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/07/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Toasted Vanilla Sweet & Shimmer Antibacterial Hand Sanitizer Spray
62651-015-01
Base4 Ventures (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Sparkling Rose Sweet & Shimmer Antibacterial Hand Sanitizer Spray
62651-016-01
Base4 Ventures (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Sweet and Shimmer Gum Drop Hand Sanitizer
62651-024-01
Base4 Ventures (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Sweet and Shimmer Pepper Mint Hand Sanitizer
62651-025-01
Base4 Ventures (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Sweet and Shimmer Sugar Cookie Hand Sanitizer
62651-026-01
Base4 Ventures (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Sweet and Shimmer Sweet Pomegranate Hand Sanitizer Spray
62651-027-01
Base4 Ventures (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Pharmacy’s Prescription Instant Hand Sanitizer with Moisturizers & Vitamin E
73597-007-08
74430-006-08
Prestige Beauty Care (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Beauty Formation Alcohol Antiseptic 80% Topical Solution Hand Sanitizer
74430-001-08
Beauty Formation
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Living Essentials Corp. Hand Sanitizer Advanced Formula
74430-002-08
74430-008-08
74430-008-33
74730-002-08
78628-008-08
78628-008-33
Pacific Bridge Products, Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
TCM Advanced Hand Sanitizer with Aloe
74430-003-02
74430-003-08
77952-003-02
77952-003-08
Tradecom Int. Inc. (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Rinse-Free Hand Sanitizer Soothing Gel 70% Alcohol Antiseptic
74430-004-16
74430-004-33
78304-004-16
78304-004-33
Blakemore Sales Corp (Missouri)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Bloom Health Antibacterial Hand Sanitizer
74430-005-02
74430-005-10
74430-005-33
77707-005-02
77707-005-10
77707-005-33
Magnet Fragrance
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Nevada National Products Antibacterial Hand Sanitizer Aloe Vera
74430-007-02
74430-007-10
74430-007-33
78462-007-02
78462-007-10
78462-007-33
Nevada Group, LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Watson Hand Sanitizer with Aloe
74430-010-01
Tash Market Place
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Watson Hand Sanitizer with Aloe
74430-010-02
90061-011-01
90061-011-02
90061-011-03
90061-011-04
Watson
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Watson Hand Sanitizer with Aloe
74430-010-03
Beauty Formation
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Watson Hand Sanitizer
74430-011-01
Tash Market Place
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Watson Hand Sanitizer
74430-011-02
90061-010-01
90061-010-02
90061-010-03
90061-010-04
Watson
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Watson Hand Sanitizer
74430-011-03
Beauty Formation
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Beauty Formation Instant Hand Sanitizer
74430-013-01
74430-013-02
74430-013-03
Beauty Formation
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Element Control Rinse-Free Hand Sanitizer Soothing Gel
74430-014-01
74430-014-02
79995-002-01
79995-002-02
Strategic Orient Sourcing Limited (Hong Kong)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Living Essentials Corp Hand Sanitizer
74430-015-59
Living Essentials Corp. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
EASTLAB Inc.
(South Korea)
Aube Hand Sanitizer with Rich Moisture
76656-100-01
K Boom Beauty, Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Guangzhou Da’ao Cosmetics Co., Ltd.
(China)
Plant Grow Disposable Hand Sanitizer
52965-001-01
52965-002-01
52965-003-01
52965-004-01
52965-005-01
52965-006-01
52965-007-01
52965-008-01
52965-009-01
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Guangzhou Da’ao Cosmetics Co., Ltd.
(China)
Germ Shark Antibacterial Hand Sanitizer
75158-500-06
Germ Shark LLC
(Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Guangzhou Da’ao Cosmetics Co., Ltd.
(China)
CJG Instant Hand Sanitizer
77372-004-00
CJ Global Inc.
(New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Guangzhou Da’ao Cosmetics Co., Ltd.
(China)
Hand Sanitizer Gel
52965-010-01
Love 2 Design LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Guangzhou Da’ao Cosmetics Co., Ltd.
(China)
Hand Sanitizer
75758-001-01
75758-001-02
75758-001-03
75758-001-04
75758-001-05
75758-001-06
75758-001-07
75758-001-08
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Juxin (Jiangsu) New Material Packing Co., Ltd.
(China)
VizoCare Soothing Gel Hand Sanitizer
79805-001-01
79805-001-02
79805-001-03
79805-001-04
79805-001-05
79805-001-06
79805-001-07
79805-001-08
79805-001-09
79805-001-10
79805-001-11
79805-001-12
Vizocom ICT LLC (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Juxin (Jiangsu) New Material Packing Co., Ltd.
(China)
Skylite Antibacterial Wet Wipes (Benzalkonium Chloride 0.3%)
79805-002-01
Aldi (Illinois)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Juxin (Jiangsu) New Material Packing Co., Ltd.
(China)
VizoCare Multi-purpose Antibacterial Wet Wipes (Benzalkonium Chloride 0.3%)
79805-002-02
Vizocom ICT LLC (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Juxin (Jiangsu) New Material Packing Co., Ltd.
(China)
GoldEssence Wellness Multi-purpose Antibacterial Wet Wipes (Benzalkonium Chloride 0.3%)
79805-002-03
Goldessence Limited (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Juxin (Jiangsu) New Material Packing Co., Ltd.
(China)
Skylite Antibacterial Wet Wipes (Benzalkonium Chloride 0.13%)
79805-011-01
Aldi (Illinois)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Juxin (Jiangsu) New Material Packing Co., Ltd.
(China)
Omega Clean Sanitizing Wipes
79805-010-01
JAS Supply, Inc. (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Kolts Fine Spirits
(Wyoming)
Hand Sanitizer KOLTISKA K DISTILLERY Alcohol 80% Topical Solution
74244-0001-1
74244-0375-1
Koltiska Distillery
(Wyoming)
FDA tested product; contains acetaldehyde and acetal contaminants. Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
BeSafe Hand Sanitizer
77693-001-01
77693-001-02
77693-001-03
77693-001-04
77693-001-05
77693-001-06
77693-001-07
77693-001-08
BeSafe Industries, LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
1Source Advanced Hand Sanitizer Refreshing Gel
77871-001-01
77871-001-02
77871-001-03
77871-001-04
77871-001-05
77871-001-06
77871-001-07
AVS Energy, Inc. (Georgia)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
1Source Advanced Hand Sanitizer Liquid Foam
77871-002-01
77871-002-02
77871-002-03
77871-002-04
77871-002-05
77871-002-06
77871-002-07
AVS Energy, Inc. (Georgia)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
5Seconds Advanced Hand Sanitizer Liquid Foam
77871-005-01
77871-005-02
77871-005-03
77871-005-04
77871-005-05
77871-005-06
77871-005-07
AVS Energy, Inc. (Georgia)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
5Seconds Advanced Hand Sanitizer Refreshing Gel
77871-004-01
77871-004-02
77871-004-03
77871-004-04
77871-004-05
77871-004-06
77871-004-07
AVS Energy, Inc. (Georgia)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
U Instant Hand Sanitizer Classic
75112-006-01
75112-006-02
75112-006-03
75112-006-04
75112-006-05
75112-006-06
75112-006-07
75112-006-08
75112-006-09
Universal Distribution Center (New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
U Instant Hand Sanitizer Aloe Vera
52000-115-03
75112-007-01
75112-007-02
75112-007-03
75112-007-04
75112-007-05
75112-007-06
75112-007-07
75112-007-08
75112-007-09
Universal Distribution Center (New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
SPIRITZ IT 2 in 1 Pen with Hand Sanitizer
75112-008-01
DMM (Illinois)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
Rilakkuma Aloe Vera Scented Hand Sanitizer
75112-009-01
Aliquantum International, Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
Yixin Sunlin Instant Hand Sanitizer
75112-001-01
75112-001-02
75112-001-03
75112-001-04
75112-001-05
75112-001-06
75112-001-07
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
Yixin Sunlin Instant Hand Sanitizer
75112-005-01
75112-005-02
75112-005-03
75112-005-04
75112-005-05
75112-005-06
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
SUDESAN Hand Sanitizer Original
75112-002-01
75112-002-02
75112-002-03
75112-002-04
75112-002-05
75112-002-06
75112-002-07
75112-002-08
XM Wholesale (Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
Health Smart Instant Hand Sanitizer
75112-003-01
75112-003-02
75112-003-03
75112-003-04
75112-003-05
75112-003-06
75112-003-07
75112-003-08
HomeSmart Products (Michigan)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
Healing Solutions Premium Hand Sanitizer
75112-004-01
75112-004-02
75112-004-03
75112-004-04
75112-004-05
75112-004-06
75112-004-07
75112-004-08
75112-004-09
75112-004-10
Healing Solutions, LLC (Arizona)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
EASTLAB Inc.
(South Korea)
D6 Plants Hand Sweeper (70% Alcohol)
76656-101-01
K Boom Beauty, Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
Disinfectant Gel Advanced Formula (75% alcohol)
76714-001-01
76714-001-03
76714-001-05
76714-001-07
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
Disinfectant Gel Advanced Formula (75% alcohol)
76714-001-01
76714-001-03
76714-001-05
76714-001-07
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
Korusa 75% Alcohol Hand Sanitizer Gel
76714-001-02
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
CB Advanced Hand Sanitizer
76714-001-04
CB Distributors, Inc. (Wisconsin)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
Dew’s Plus Disinfectant Gel Hand Sanitizer
76714-001-06
Magic Trade INC (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
AuraFresh Kids Hand Sanitizer
76714-001-07
TopGrade Products Inc (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
Disinfectant (75% alcohol)
76714-002-01
76714-002-02
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
AuraFresh 75% Alcohol Spray Disinfectant & Antimicrobial
76714-002-03
76714-002-04
TopGrade Products Inc (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
AuraFresh 75% Alcohol Ethyl Rubbing Alcohol
76714-002-05
TopGrade Products Inc (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guizhou Xinzihong Pharmaceutic Adjuvant Co., Ltd.
(China)
Alcohol-Based Disinfectant Hand Sanitizer Gel (75% alcohol)
74757-001-01
74757-001-02
74757-001-03
74757-002-01
74757-002-02
74757-002-03
74757-002-04
74757-002-05
74757-002-06
74757-002-07
74757-002-08
74757-002-09
74757-002-10
74757-002-11
74757-002-12
74757-002-13
ATZ Med Supply (Maryland)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guizhou Xinzihong Pharmaceutic Adjuvant Co., Ltd.
(China)
LiveLife Corp. 75% Alcohol-Based Disinfectant Hand Sanitizer Gel
79606-001-01
79606-001-02
79606-001-03
79606-001-04
79606-001-05
79606-001-06
79606-001-07
79606-001-08
79606-001-09
79606-001-10
79606-001-11
LiveLife Corp. (Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guizhou Xinzihong Pharmaceutic Adjuvant Co., Ltd.
(China)
LiveLife Corp. 75% Alcohol-Based Disinfectant Hand Sanitizer Gel
79606-002-01
79606-002-02
79606-002-03
79606-002-04
79606-002-05
79606-002-06
79606-002-07
79606-002-08
79606-002-09
79606-002-10
79606-002-11
LiveLife Corp. (Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Shandong Oushile Biotechnology Co., Ltd.
(China)
Lifeguard Multi Purpose Antiseptic Alcohol Wipes
77879-003-01
78781-001-01
78781-006-01
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Shandong Oushile Biotechnology Co., Ltd.
(China)
Pro Clean Hand Sanitizer
78781-311-10
78781-311-75
Bigbattery Inc (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Shandong Oushile Biotechnology Co., Ltd.
(China)
Blue Unity 75% Alcohol Wet Wipes
78781-080-50
78781-080-75
78781-408-01
78781-408-04
78781-531-10
78781-531-40
RIXI Group USA Inc (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Yiwu Mango Cosmetics, Ltd.
(China)
Instant Hand Sanitizer (Alcohol 75%)
76824-001-01
76824-001-02
76824-001-03
76824-001-04
76824-001-05
76824-001-06
76824-001-07
76824-001-08
76824-001-09
76824-001-10
76824-001-11
76824-001-12
76824-001-13
Yiwu Mango Cosmetics, Ltd.
(China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 6/12/2023.
05/24/2023
Laavo Clean, S.A. de C.V.
(Mexico)
Beyond Simple Cleaners Instant Hand Sanitizer with Glycerin (Benzalkonium Chloride 0.13%) 3790mL
80806-520-02
Laavo Clean, S.A. de C.V.
(Mexico)
FDA tested product; benzalkonium chloride level was subpotent. FDA has no evidence this product is in the U.S. market; added to import alert to help stop their products from entering the U.S. on 05/9/2023; FDA issued a warning letter on 08/07/2023.
05/17/2023
Laavo Clean, S.A. de C.V.
(Mexico)
Beyond Simple Cleaners Instant Hand Sanitizer with Glycerin (Benzalkonium Chloride 0.13%) 60mL
80806-520-03
Laavo Clean, S.A. de C.V.
(Mexico)
FDA tested product; benzalkonium chloride level was superpotent. FDA has no evidence this product is in the U.S. market; added to import alert to help stop their products from entering the U.S. on 05/9/2023; FDA issued a warning letter on 08/07/2023.
05/17/2023
Laavo Clean, S.A. de C.V.
(Mexico)
Kids Instant Hand Sanitizer (Benzalkonium Chloride 0.13%)
80806-510-01
80806-510-02
80806-510-03
80806-510-04
Laavo Clean, S.A. de C.V.
(Mexico)
FDA tested product; benzalkonium chloride level was superpotent. FDA has no evidence this product is in the U.S. market; added to import alert to help stop their products from entering the U.S. on 05/9/2023; FDA issued a warning letter on 08/07/2023.
05/17/2023
Haining Twowell Daily Commodity Co., Ltd.
(China)
Activa Hand Sanitizer Wipes
80552-001-01
80552-001-02
Blue Ribbon Supply Company
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 05/22/2023.
05/03/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd
(China)
Mayseen Instant Hand Sanitizer
78565-016-01
Skyelee Inc
(Georgia)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023
04/26/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd
(China)
Vivitar Advanced Hand Sanitizer
Unspecified
Sakar International
(New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023
04/26/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd
(China)
Healing Solutions Premium Hand Sanitizer
Unspecified
Healing Solutions LLC
(Arizona)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023
04/26/2023
Natuurs Direct, LLC
(Nevada)
Natuurs Advance Hand Sanitizer Alcohol Antiseptic 80%
75393-4800-5
Natuurs Direct, LLC
(Nevada)
Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and scope of contamination.
04/19/2023
Natuurs Direct, LLC
(Nevada)
Natuurs Pure Liquid Sanitizer Hand & Surface Alcohol Antiseptic 80%
Not listed
Natuurs Direct, LLC
(Nevada)
FDA tested product; contains acetaldehyde and acetal contaminants; Company did not adequately respond to FDA requests for records and other information related drug manufacturing, product quality and scope of the contamination.
04/19/2023
Jarman’s Midwest Cleaning Systems, Inc. (South Dakota)
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution
74663-001-04
74663-001-12
74663-001-55
MCS Midwest Cleaning Solutions (South Dakota)
FDA tested product; contains unacceptable levels of methanol; FDA recommended the company recall on 3/22/2023; product voluntarily recalled on 3/27/2023.
04/12/2023
Jarman’s Midwest Cleaning Systems, Inc. (South Dakota)
Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution
74663-002-04
74663-002-55
74663-002-01
MCS Midwest Cleaning Solutions (South Dakota)
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 3/22/2023; product voluntarily recalled on 3/27/2023.
04/12/2023
Jarman’s Midwest Cleaning Systems, Inc. (South Dakota)
SOFT HANDS Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution
77518-200-01
Clean Pro Supply, LLC (New York)
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 3/22/2023; product voluntarily recalled on 3/27/2023.
04/12/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China)
Macy’s Antibacterial Hand Sanitizer Gel (75% ethyl alcohol)
Unspecified
MiWorld Accessories, LLC. (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023.
04/12/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China)
Isaac Mizrahi New York Hand Sanitizer
Unspecified
MWA, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023.
04/12/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China)
C Wonder Hand Sanitizing Spray
Unspecified
MWA, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023.
04/12/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China)
L+W Bio Hygienic Hand Sanitizer
78713-002-08
Luxe + Willow / MWA (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023.
04/12/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China)
C Wonder Sanitizing Gel
Unspecified
MiWorld Accessories LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023.
04/12/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China)
Sanitize Keep Hands Clean Luxe + Willow Hand Sanitizer
Unspecified
Luxe + Willow / MWA (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023.
04/12/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China)
Lifeguard Hand Sanitizer
Unspecified
Lifeguard (Nevada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/24/2023.
04/12/2023
(South Korea)
(South Korea)
(South Korea)
75535-0002-1
(South Korea)
(China)
74935-014-00
76813-005-00
76813-014-00
73529-353-01
(China)
(China)
(China)
74935-014-00
76813-005-00
76813-014-00
73529-353-01
(China)
52728-002-01
52728-003-01
52728-004-01
52728-005-01
52728-006-01
52728-007-01
52728-008-01
52728-010-01
52728-011-01
52728-012-01
52728-013-01
52728-014-01
52728-015-01
52728-017-01
52728-018-01
52728-019-01
79485-100-10
79485-100-20
79485-100-30
(China)
(China)
74871-050-01
74871-060-00
74871-060-01
74871-100-00
74871-100-01
(New Mexico)
(China)
74871-051-01
74871-061-00
74871-061-01
74871-120-00
74871-120-01
74871-237-00
74871-237-01
74871-500-00
74871-500-01
74871-900-00
74871-900-01
(New Mexico)
(China)
77725-002-01
(China)
77725-003-08
77725-003-17
77725-003-33
77725-004-08
(China)
79195-005-01
79195-006-01
(China)
77813-001-04
(United Arab Emirates)
68210-4079-2
68210-4079-3
(United Arab Emirates)
(United Arab Emirates)
68210-4081-2
68210-4081-5
(United Arab Emirates)
(United Arab Emirates)
68210-4075-2
68210-4075-3
68210-4075-4
68210-4075-5
68210-4075-6
68210-4075-7
68210-4075-8
(United Arab Emirates)
68210-4118-5
68210-4118-6
(South Korea)
(South Korea)
77799-057-01
77799-170-01
77799-370-01
77799-570-01
(South Korea)
75368-010-02
75368-020-01
75368-020-02
75368-030-01
75368-030-01
(South Korea)
(South Korea)
(South Korea)
74003-020-01
74003-030-01
Zhongshan Dermey Commodity Co., Ltd.
(China)
JM & HFB Disinfection Instant Hand Sanitizer, 75% alcohol
55028-001-01
55028-002-01
55028-003-01
55028-004-01
55028-005-01
55028-006-01
55028-007-01
55028-008-01
55028-009-01
55028-010-01
Zhongshan Dermey Commodity Co., Ltd.
(China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 03/27/2023.
03/22/2023
Zhongshan Dermey Commodity Co., Ltd.
(China)
360+ Bio-Lab Advanced Hand Fragrance Free Antimicrobial Gel, 75% alcohol
55028-011-01
Asia Bay, Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 03/27/2023.
03/22/2023
Zhongshan Dermey Commodity Co., Ltd.
(China)
360+ Bio-Lab Advanced Hand Sanitizer Spray, 70% alcohol
55028-012-01
55028-013-01
Asia Bay, Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 03/27/2023.
03/22/2023
Zhongshan Dermey Commodity Co., Ltd.
(China)
ShieldOurs Hand Sanitizer Refreshing Gel, 75% alcohol
55028-015-01
55028-015-02
Zhongshan Dermey Commodity Co., Ltd.
(China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 03/27/2023.
03/22/2023
Zhongshan Dermey Commodity Co., Ltd.
(China)
ProtectorPlus Alcohol Hand Wipes, 75% alcohol
78378-666-01
78378-666-02
78378-666-05
78378-666-06
78378-666-07
78378-666-08
Cancreativ Packing Corp
(Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 03/27/2023.
03/22/2023
Zhongshan Dermey Commodity Co., Ltd.
(China)
ProtectorPlus Hand Sanitizer, 75% alcohol
78378-888-01
78378-888-02
78378-888-03
78378-888-04
78378-888-05
78378-888-06
78378-888-07
78378-888-08
Cancreativ Packing Corp
(Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 03/27/2023.
03/22/2023
Yiwu Dieyuan Cosmetics Co., Ltd. (China)
Hand Sanitizer
75612-030-01
Yiwu Dieyuan Cosmetics Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/10/2023.
03/22/2023
Yiwu Dieyuan Cosmetics Co., Ltd. (China)
Instant Hand Sanitizer
75612-100-01
Yiwu Dieyuan Cosmetics Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/10/2023.
03/22/2023
Yiwu Dieyuan Cosmetics Co., Ltd. (China)
Beesoul Instant Hand Sanitizer
75612-101-01
75612-101-02
75612-101-03
75612-101-04
75612-101-05
75612-101-06
75612-101-10
75612-101-13
75612-101-15
75612-101-25
75612-101-37 75612-101-50
Yiwu Dieyuan Cosmetics Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/10/2023.
03/22/2023
St. Augustine Distillery LLC
(Florida)
St. Augustine Distillery Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution
74324-001-01
74324-001-02
St. Augustine Distillery LLC (Florida)
FDA tested product; contains acetaldehyde and acetal contaminants. Company did not respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination.
03/22/23
Raff Beverage LLC
(California)
Take A Bite Out Of Germs Hand Sanitizer
74610-008-01
74610-008-08
74610-008-16
74610-008-75
Raff Distillerie
(California)
FDA tested product; contains acetaldehyde and acetal contaminants. Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination.
03/22/2023
74416-171-03
74416-171-04
74416-171-08
74416-171-10
74416-171-16
74416-171-35
74416-172-51
73750-369-01
73750-369-02
73750-369-03
73750-369-04
73750-369-05
73750-369-06
73750-369-07
Guangzhou Yilong Cosmetics Co., Ltd.
(China)
Siruini Hand Sanitizer
74458-101-01
74458-101-02
74458-101-03
74458-101-04
74458-101-05
74458-101-06
74458-101-07
74458-101-08
74458-101-09
74458-101-10
Guangzhou Yilong Cosmetics Co., Ltd.
(China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/05/2023.
03/22/2023
Guangzhou Yilong Cosmetics Co., Ltd.
(China)
Village Pharma Sanizen Gel Hand Sanitizer (75% alcohol)
74458-201-01
71574-711-10
Village Pharma, LLC
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 4/05/2023.
03/22/2023
Guangzhou Meizi Biotechnology Co., Ltd
(China)
Jean Pierre Cosmetics Antibacterial Hand Gel
79867-002-01
79867-002-02
79867-002-03
70483-018-01
70483-018-02
70483-018-03
Jean Pierre Inc.
(New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/03/2023
03/22/2023
Guangzhou Meizi Biotechnology Co., Ltd
(China)
Expressions Hand Sanitizer
79867-001-01
Almar Sales Co.
(New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/03/2023
03/22/2023
Guangzhou Cikang Biotechnology Co., Ltd.
(China)
Smart Care Advanced Hand Sanitizer
70108-070-01
74416-005-01
Ashtel Studios Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/03/2023
03/15/2023
Guangzhou Cikang Biotechnology Co., Ltd.
(China)
Smart Care Hand Sanitizer Aloe Vera & Vitamin E
70108-038-01
70108-039-01
70108-040-01
70108-041-01
74416-001-01
74416-002-01
74416-003-01
74416-004-01
Ashtel Studios Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/03/2023
03/15/2023
Guangzhou Cikang Biotechnology Co., Ltd.
(China)
HiGuys USA Alcohol Disinfectant
74416-170-01
74416-170-02
74416-170-03
74416-170-04
74416-170-05
74416-170-06
74416-170-07
74416-170-08
74416-170-09
74416-170-10
Lancougroup
(China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 04/03/2023
03/15/2023
Nanomaterials Discovery Corporation
(Wyoming)
Snowy Range Blue alcohol antiseptic 80% topical solution
75288-100-01
75288-100-02
75288-100-04
75288-100-06
Reliable Products, LLC
(Wyoming)
FDA tested product; contains unacceptable levels of methanol, acetaldehyde and acetal; FDA recommended the company recall on 2/9/2023; product voluntarily recalled on 2/14/2023.
03/08/2023
Innovaciones Tecnologicas Concar, SA de CV
(Mexico)
SQ2SKIN Skin Care, Antiseptic Hand Sanitizer Foam (Benzalkonium Chloride 0.13%)
79279-420-01
79279-420-02
79279-420-03
79279-420-04
79279-420-05
79279-421-06
79279-421-07
79279-421-08
79279-421-09
79279-421-10
79279-520-06
79279-520-07
79279-520-08
79279-520-09
79279-521-01
79279-521-02
79279-521-03
79279-521-04
79279-521-05
79279-610-01
79279-610-02
79279-610-03
79279-610-04
79279-610-05
79279-620-01
79279-620-02
79279-620-03
79279-620-04
79279-620-05
Innovaciones Tecnologicas Concar, SA de CV
(Mexico)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
02/22/2023
Coppercraft Distillery, LLC
(Michigan)
Hand Sanitizer Topical Solution, Alcohol Antiseptic 80%
75293-001-02
75293-001-04
75293-001-03
75293-001-01
Coppercraft Distillery, LLC
(Michigan)
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination.
02/22/2023
Ublendit, Inc.
(California)
Hideout Hand Sanitizer non-sterile solution Alcohol Antiseptic 80% Topical Solution
74515-111
Ublendit, Inc.
(California)
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination.
02/15/2023
Dongguan Mingyi Medical Products, Co., Ltd. (China)
Hand Sanitizer Gel
74046-001-01
74046-001-02
74046-001-03
74046-001-04
74046-001-05
74046-001-06
74046-001-07
74046-001-08
74046-001-09
74046-001-10
74046-001-11
74046-001-12
74046-001-13
74046-001-14
74046-001-15
74046-001-16
74046-001-17
74046-001-18
74046-001-19
74046-001-20
Dongguan Mingyi Medical Products, Co., Ltd.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 01/05/2023
02/01/2023
Dongguan Mingyi Medical Products, Co., Ltd. (China)
Hand Sanitizer Spray
74046-004-01
74046-004-02
74046-004-03
74046-004-04
74046-004-05
74046-004-07
74046-004-08
74046-004-09
74046-004-10
Dongguan Mingyi Medical Products, Co., Ltd.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 01/05/2023
02/01/2023
Dongguan Mingyi Medical Products, Co., Ltd. (China)
Benzalkonium Chloride Instant Hand Sanitizer
74046-006-01
74046-006-02
74046-006-03
74046-006-04
74046-006-05
74046-006-06
74046-006-07
74046-006-08
74046-006-09
74046-006-10
Dongguan Mingyi Medical Products, Co., Ltd.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 01/05/2023.
02/01/2023
Drivergent, Inc.
(Michigan)
Drivergent Hand Sanitizer, Alcohol Antiseptic 80% Topical Solution, Antiseptic Hand Rub, Non-Sterile Solution,
75037-0001-1
Drivergent, Inc.
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023; FDA issued a warning letter on 05/01/2023.
02/01/2023
Drivergent, Inc.
(Michigan)
Drivergent Hand Sanitizer, 80% Alcohol Antiseptic Topical Hand Rub, Non-Sterile, 1 Quart, 32 FL OZ (0.95 L)
Not listed
Drivergent, Inc.
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023; FDA issued a warning letter on 05/01/2023.
02/01/2023
Drivergent, Inc.,
(Michigan)
Drivergent Hand Sanitizer 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution, Gel, 8 FL OZ (250 ml)
Not listed
Drivergent, Inc.
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023; FDA issued a warning letter on 05/01/2023.
02/01/2023
Drivergent, Inc.
(Michigan)
Drivergent Hand Sanitizer, 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution
75037-0002-1
Drivergent, Inc.
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023; FDA issued a warning letter on 05/01/2023.
02/01/2023
Sun Wave Wellness, LLC
(Florida)
Sun Wave Antiseptic Hand Sanitizer Alcohol Antiseptic 70% Enriched with Aloe Clean Scent
75023-0002
75023-0003
75023-0004
75023-0005
Sun Wave Wellness, LLC
FDA tested product; contains unacceptable levels of acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination.
01/18/2023
Frenda Corporation
(Puerto Rico)
Global Care Antibacterial Hand Sanitizer
74115-000-00
72146-000-01
72146-020-01
Target Price Inc.
(Puerto Rico)
Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. FDA recommended the company recall all drug products on 12/12/2022; FDA issued a warning letter on 02/15/2023.
12/21/2022
Frenda Corporation
(Puerto Rico)
Easy Klean Hand Sanitizer
Frenda Corporation
(Puerto Rico)
Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. FDA recommended the company recall all drug products on 12/12/2022; FDA issued a warning letter on 02/15/2023.
12/21/2022
Mohawk Laboratories Division
(Texas)
Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution
55533-524-01
55533-524-02
55533-524-03
55533-524-04
MULTI-MIST Products
(Texas)
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 11/29/2022.
12/14/2022
Ultra Chem Labs, Corp.
(California)
Proton Armor Antimicrobial Alcohol-Free Foaming Hand Sanitizer
79208-001-32
79208-001-01
Ultra Chem Labs
Company did not respond adequately to multiple FDA requests for records and other information related to drug manufacturing, product quality and questions regarding possibility of methanol contamination which cannot be ruled out; after FDA recall recommendation, the firm announced a voluntary recall on 10/18/2022; FDA issued a warning letter on 12/20/2022.
11/16/2022
Adam’s Polishes LLC
(Colorado)
Alcohol Based Hand Sanitizer, Isopropyl Antiseptic 75%. Topical Solution
74943-125-08
74943-125-16
74943-125-28
B&B Blending, LLC,
Northglenn, CO
FDA tested product; contains methanol; product voluntarily recalled on 11/5/2022.
11/16/2022
Urban Electric Power
(New York)
Ohm Sanitizer Spray 80% alcohol
Urban Electric Power
(New York)
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; FDA recommended the company recall on 10/18/2022; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and scope of the contamination.
11/09/2022
Urban Electric Power
(New York)
Ohm Hand Sanitizer 70% Alcohol
Urban Electric Power
(New York)
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; FDA recommended the company recall on 10/18/2022; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and scope of the contamination.
11/09/2022
Flavor Vapors, LLC, dba: Mob Liquid Labs
(Nevada)
Mob Liquid Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution
Flavor Vapors, LLC
FDA tested product; isopropyl alcohol level was subpotent; FDA recommended the company recall on 10/13/2022
10/19/2022
Salon Technologies International
(Florida)
Salon Technologies International Sanitizing Hand Spray 80%
Salon Technologies International
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; after FDA contacted the firm, firm’s testing identified benzene in another product. FDA recommended the company recall on 9/14/2022; product voluntarily recalled on 9/17/2022; FDA issued a warning letter on 12/21/2022.
10/06/2022
Salon Technologies International
(Florida)
Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%
80097-007-01
Antica Farmacista
Company tested product; contains benzene. FDA recommended the company recall on 9/14/2022; product voluntarily recalled lot 1166A on 9/17/2022; FDA issued a warning letter on 12/21/2022.
10/06/2022
Unibeleza Industria E Comercio De
–
Cosmeticos Ltda, (Brazil)
Biotipo Pharma Medical Antibacterial Antiseptic Cleanser Disinfectant
77457-015-01
Biotipo Brazil
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 10/18/2022
09/14/2022
Venice Cosmetic (Korea)
Reborncare Hand Sanitizer (100mL, 250mL, 500mL)
79486-101-01
79486-102-01
Reborncare Co. Ltd
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/09/2022.
08/17/2022
Venice Cosmetic (Korea)
Natural Bloom Hand Sanitizer Gel
Natural Bloom
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/09/2022.
08/17/2022
Venice Cosmetic (Korea)
MAY MEDIC Clean Sanitizer gel
74488-500-02
Venice Cosmetic
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/09/2022.
08/17/2022
Zorin Pharmaceutical Technology Co. Ltd. (China)
PEI FAN Instant Hand Sanitizer with Aloe
75183-006-02
75183-006-03
75183-006-04
75183-006-05
75183-006-06
75183-006-07
Zorin Pharmaceutical Technology Co. Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 10/12/2022
09/14/2022
Zorin Pharmaceutical Technology Co. Ltd. (China)
Safe Hand Sanitizer with Aloe
K&B Global Corp
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 10/12/2022
09/14/2022
Zorin Pharmaceutical Technology Co. Ltd. (China)
Zorari Waterless Disinfection Gel
75183-010-02
75183-010-03
Zorin Pharmaceutical Technology Co. Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 10/12/2022
09/14/2022
Unibeleza Industria E Comercio De
–
Cosmeticos Ltda, (Brazil)
Biotipo Pharma Medical Sanitizing Hand Wipes
77457-011-02
77457-011-03
77457-012-01
77457-012-02
77457-013-01
77457-013-02
77457-013-03
Biotipo Brazil
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 10/18/2022
09/14/2022
Unibeleza Industria E Comercio De
–
Cosmeticos Ltda, (Brazil)
Biotipo Pharma Medical Biogel
77457-000-02
77457-000-03
77457-000-04
77457-000-05
77457-000-06
77457-000-07
77457-000-08
77457-001-01
77457-001-02
77457-001-03
77457-001-04
77457-001-05
77457-002-01
77457-002-02
77457-002-03
77457-006-01
Biotipo Brazil
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 10/18/2022
09/14/2022
Venice Cosmetic
(Korea)
LK Hand Clean Gel
(Ethanol)
Venice Cosmetic
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/09/2022.
08/17/2022
Venice Cosmetic
(Korea)
LK New Antiseptic
(Ethanol)
74488-011-01
Venice Cosmetic
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/09/2022.
08/17/2022
Venice Cosmetic
(Korea)
LK Clean Gel
(Ethanol)
74488-002-01
74488-004-01
74488-005-01
74488-006-01
74488-007-01
74488-008-01
74488-009-01
Venice Cosmetic
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/09/2022.
08/17/2022
Skin Farm
(Korea)
PalmShield Hand Sanitizer Gel with Aloe and Coconut Oil
73793-0007-1
73793-0008-1
Sports Med Care, Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2022.
08/17/2022
Skin Farm
(Korea)
Germ War Hand Sanitizer
73793-0002-1
73793-0003-1
73793-0004-1
73793-0005-1
73793-0009-1
73793-0010-1
73793-0011-1
73793-0012-1
DJO LLC.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2022.
08/17/2022
Clean Cosmetics, LLC
(California)
TrustRx Medical Grade Hand Sanitizer
80843-001-01
80843-001-02
80843-001-03
Clean Cosmetics, LLC
(California)
Product contains methanol based on information provided by the manufacturer. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; FDA issued a warning letter on 01/30/2023.
08/03/2022
Guangdong Theaoson Technology Co. Ltd. (China)
75% Alcohol Hand Sanitizer Gel
78792-012-04
78792-012-06
78792-012-07
Guangdong Theaoson Technology Co., Ltd.
(China)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong Theaoson Technology Co. Ltd. (China)
Antibacterial Hand Sanitizer with Moisturize
Aloe
78792-012-05
Guangdong Theaoson Technology Co., Ltd.
(China)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong Theaoson Technology Co. Ltd. (China)
75% Alcohol Sanitizer
78792-010-01
78792-012-01
78792-012-02
78792-012-03
Guangdong Theaoson Technology Co., Ltd. (China)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong JunBao Industry Co. Ltd. (China)
One Drop Care Hand Disinfectant Gel
75226-004-01
75226-004-02
75226-004-03
75226-004-04
75226-004-05
Guangzhou Wantuo Biotechnology Co LTD
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong Theaoson Technology Co. Ltd. (China)
75% Alcohol Sanitizer Spray
78792-011-01
78792-011-02
78792-011-03
78792-011-04
Guangdong Theaoson Technology Co., Ltd.
(China)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong JunBao Industry Co. Ltd. (China)
JPR Medical Disinfecting Wipes (75% alcohol)
54325-004-01
Guangdong JunBao Industry Co., Ltd.
(China)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong JunBao Industry Co. Ltd. (China)
Alcohol Cleaning Wet Wipes
54325-001-01
54325-002-01
Guangdong JunBao Industry Co., Ltd.
(China)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong JunBao Industry Co. Ltd. (China)
Be Cleaner Be Healthier 75% Alcohol Wipes
54325-003-01
BM Time Co.
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong JunBao Industry Co. Ltd. (China)
One Drop Care Alcohol Disinfectant Spray
75226-001-01
75226-001-02
75226-001-03
75226-001-04
Guangzhou Wantuo Biotechnology Co. LTD
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong JunBao Industry Co. Ltd. (China)
One Drop Care Alcohol Disinfectant Wet Wipes
75226-002-01
75226-002-02
75226-002-03
75226-002-04
Guangzhou Wantuo Biotechnology Co LTD
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong JunBao Industry Co. Ltd. (China)
One Drop Care Alcohol Solution
75226-003-01
75226-003-02
75226-003-03
Guangzhou Wantuo Biotechnology Co LTD
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
(Louisiana)
Say Goodbye to Germs
Alcohol Antiseptic 80% Topical Solution
(Louisiana)
(Louisiana)
76701-700-08
76701-700-17
76701-700-32
75339-751-01
75339-751-02
75339-751-03
75339-751-04
75339-751-05
75339-751-06
75076-123-55
75076-234-55
Not listed
80751-200-02
80751-300-07
Dongguan Chunzhen Biological Technology Co., Ltd (China)
HealthMEDS, Inc. Oregon)
HealthMEDS, Inc. (Oregon)
60599-018-02
60599-018-04
60599-015-02
60599-012-08
60599-012-01
60599-012-02
60599-012-03
60599-012-05
60599-012-06
60599-012-07
60599-012-10
60599-013-01
60599-014-00
60599-018-04
60599-018-06
60599-018-07
60599-018-01
60599-018-02
60599-018-04
60599-018-06
60599-018-07
60599-018-01
60599-018-03
60599-018-05
60599-018-08
60599-019-00
60599-020-01
74840-402-01
72758-002-08
72758-003-01
72758-005-01
72758-005-02
72758-005-03
77927-100-11
77927-100-08
77927-100-06
77927-100-09
77927-100-10
75192-002-04
75192-002-02
75192-003-02
75192-003-03
75192-600-01
(Poland)
78571-002-03
78571-002-04
78471-002-05
(Poland)
78581-001-02
78581-001-03
78581-001-04
78571-001-05
78571-001-06
Bionateo Sp z.o.o.(Poland)
Bionateo Sp z.o.o. (Poland)
Bionateo Sp z.o.o. (Poland)
Bionateo Sp z.o.o.(Poland)
78571-005-01
78571-005-02
78571-005-03
74001-0002-1
74001-0004-1
74001-0005-1
74001-0006-1
BVG Zero Hand Sanitizer
BVG Clean Hand Sanitizer
74001-0001-1
74001-0003-1
75585-030-01
75585-050-01
75585-050-02
75585-050-03
75585-070-01
75585-070-02
75585-070-03
75585-070-04
75585-040-01
75585-060-01
51384-001-02
51384-003-02
51384-500-11
51384-500-23
51384-500-47
51384-500-94
73762-100-11
73762-100-23
73762-100-47
73762-100-94
78072-400-11
78072-400-23
78072-400-47
78072-400-94
78072-500-11
78072-500-23
78072-500-47
78072-500-94
75179-313-05
75179-313-16
62583-020-33
62583-020-42
74673-001-16
74673-001-33
74673-001-42
79081-000-02
79081-000-04
78533-000-02
78533-000-08
78533-000-16
78533-000-33
(Korea)
74949-002-25
74949-002-49
74949-002-60
74155-211-07
74155-211-08
74155-211-19
74155-211-20
74155-211-38
74155-201-19
74155-201-20
74155-201-38
74155-111-08
74155-111-19
74155-111-20
74155-111-38
74155-101-08
74155-101-19
74155-101-20
74155-101-38
73009-003-04
73009-003-32
73009-002-02
75408-002-01
75408-002-02
73009-005-02
73009-005-03
73009-005-04
73009-005-05
73009-005-06
79284-005-00
73009-015-02
79695-015-01
79695-015-02
62400-0016-1
62400-0017-1
73009-018-02
73009-018-03
73009-018-04
73009-018-05
81081-000-01
81081-000-02
81081-000-03
81081-000-04
81081-000-05
76527-001-02
76527-001-04
76527-001-05
76527-001-06
76527-001-07
78907-001-02
78907-001-03
78907-001-04
78907-001-05
76527-002-02
76527-002-03
76527-002-04
76527-002-05
76527-002-06
76527-002-07
76527-002-02
76527-003-02
76527-003-03
76527-003-04
76527-003-05
76527-003-06
76527-003-07
76527-003-08
75799-000-04
76938-001-03
72384-001-02
78384-001-03
78384-001-04
74625-002-04
74625-002-05
74625-003-01
74625-003-04
74625-003-05
76988-001-03
78718-763-02
78718-763-03
78718-763-04
78718-763-05
78718-763-06
74484-001-02
74484-001-03
74484-001-04
74484-002-01
74484-002-02
74484-002-03
74484-002-04
74484-002-05
74484-002-06
76612-170-10
76612-170-11
76612-170-12
76612-170-25
76612-170-37
76612-170-50
76612-180-10
76612-180-12
76612-180-25
76612-180-37
76612-180-50
77409-170-10
77409-170-11
77409-170-12
77409-170-25
77409-170-37
77409-170-50
77409-180-10
77409-180-12
77409-180-25
77409-180-37
77409-180-50
79109-170-10
79109-170-11
79109-170-12
79109-170-22
79109-170-25
79109-170-37
79109-170-50
75744-0200-4
75744-0201-5
75744-0202-1
75744-0250-1
75744-0250-2
75744-0500-1
75744-1000-1
75744-1000-3
75744-1001-1
75432-001-01
75432-001-03
75432-001-04
76592-002-02
76592-002-03
76592-002-04
76592-002-05
76592-002-06
76592-002-07
76592-001-02
76592-001-03
76592-001-04
76592-003-02
76592-004-01
76592-004-02
75132-001-02
75132-001-03
75132-001-04
75132-001-05
75132-001-06
75132-001-07
75132-001-08
75132-001-09
75132-001-10
75132-001-11
75132-001-12
75132-001-13
75132-001-14
75132-001-15
75132-001-16
75132-001-17
75132-002-02
75132-002-03
75132-002-04
75132-002-05
75132-002-06
75132-002-07
75132-002-08
75132-002-09
75132-002-10
75132-011-02
75132-011-03
77205-001-02
77205-002-02
Guangdong Longtai Industry Co., Ltd. (China)
Vertra Hand Sanitizer Topical Solution
52807-103-01
52807-103-02
52807-103-03
52807-103-04
52807-103-05
52807-103-06
52807-103-07
52807-103-08
52807-103-09
52807-103-10
EAI-JR286 Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/05/2022
06/08/2022
Guangdong Longtai Industry Co., Ltd. (China)
“ssential” Hand Sanitizer
52807-002-01
52807-003-01
52807-004-01
52807-005-01
52807-006-01
52807-007-01
52807-008-01
52807-009-01
52807-010-01
52807-011-01
52807-012-01
52807-013-01
52807-014-01
LLF Phoenix LLC
(Nevada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangdong Longtai Industry Co., Ltd. (China)
“ssential” Aloe Vera Gel Hand Sanitizer
52807-015-01
52807-016-01
52807-017-01
52807-018-01
52807-019-01
52807-020-01
LLF Phoenix LLC
(Nevada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangdong Longtai Industry Co., Ltd. (China)
“ts” By Tara – Clean Up Hand Sanitizer
52807-021-01
52807-021-02
52807-021-03
Guangdong Longtai Industry Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangdong Longtai Industry Co., Ltd. (China)
Eco-Planet Pura Advanced Hand Sanitizer
52807-001-01
Guangdong Longtai Industry Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangdong Longtai Industry Co., Ltd. (China)
Spa Da Health
PROmmunity Hand Sanitizer
52807-022-01
52807-022-02
Accel Inc.
(Ohio)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangdong Longtai Industry Co., Ltd. (China)
Healing Solutions Premium Hand Sanitizer
52807-101-01
52807-101-02
52807-101-03
52807-101-04
52807-101-05
52807-101-06
52807-101-07
52807-101-08
52807-101-09
52807-101-10
52807-101-11
52807-101-12
52807-101-13
52807-101-14
52807-101-15
52807-101-16
52807-101-17
52807-101-18
52807-101-19
52807-101-20
52807-101-21
52807-101-22
52807-101-23
52807-101-24
52807-101-25
52807-101-26
52807-101-27
52807-101-28
52807-101-29
52807-101-30
52807-101-31
52807-101-32
52807-101-33
52807-101-34
52807-101-35
52807-101-36
52807-101-37
52807-101-38
52807-101-39
52807-101-40
52807-101-41
52807-101-42
52807-101-43
52807-101-44
52807-101-45
Healing Solutions LLC
(Arizona)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangdong Longtai Industry Co., Ltd. (China)
Roots Aromatherapy Hand Sanitizer
52807-102-01
52807-102-02
52807-102-03
52807-102-04
52807-102-05
52807-102-06
52807-102-07
52807-102-08
52807-102-09
52807-102-10
52807-102-11
52807-102-12
52807-102-13
52807-102-14
52807-102-15
52807-102-16
52807-102-17
52807-102-18
52807-102-19
52807-102-20
52807-102-21
52807-102-22
52807-102-23
52807-102-24
52807-102-25
52807-102-26
52807-102-27
52807-102-28
52807-102-29
52807-102-30
52807-102-31
52807-102-32
52807-102-33
52807-102-34
52807-102-35
52807-102-36
52807-102-37
52807-102-38
52807-102-39
52807-102-40
52807-102-41
52807-102-42
52807-102-43
52807-102-44
52807-102-45
52807-102-46
52807-102-47
52807-102-48
52807-102-49
52807-102-50
52807-102-51
52807-102-52
52807-102-53
52807-102-54
52807-102-55
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangzhou Meiyichen Pharmaceutical Co. Ltd. (China)
Cisimonn
No-washing Disinfection Gel
78278-102-01
78278-102-02
78278-102-03
78278-102-04
78278-102-11
78278-102-12
78278-102-13
78278-102-14
78278-102-15
Guangzhou Meiyichen Pharmaceutical Co. Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangzhou Minghui Cosmetics Co. Ltd. (China)
Qi Yu Hand Sanitizer
74447-001-01
74447-002-01
74447-003-01
74447-004-01
74447-005-01
74447-006-01
74447-007-01
74447-008-01
74447-009-01
74447-010-01
74447-011-01
74447-012-02
74447-012-03
74447-012-04
74447-012-05
74447-012-06
74447-012-07
74447-012-08
74447-012-09
74447-012-10
Guangzhou Minghui Cosmetics Co. Ltd.
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a warning letter on 07/06/2021.
Guangzhou Minghui Cosmetics Co. Ltd. (China)
Qi Yu Medical Alcohol Disinfectant
74447-101-01
74447-101-02
74447-101-03
74447-101-04
74447-101-05
74447-101-06
74447-101-07
74447-101-08
74447-101-09
74447-101-10
74447-101-11
74447-101-12
74447-101-13
74447-101-14
74447-101-15
74447-101-16
74447-101-17
Guangzhou Minghui Cosmetics Co. Ltd.
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a warning letter on 07/06/2021.
Guangzhou Minghui Cosmetics Co. Ltd. (China)
Waxman Kleen Freak Hand Sanitizer
74447-106-01
Waxman Industries
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a warning letter on 07/06/2021.
75239-005-02
75239-005-03
75239-005-04
75239-005-05
75239-005-06
75239-005-07
75239-005-08
75239-005-10
75239-005-11
75239-005-12
75239-005-13
75239-005-14
75239-005-15
75239-005-16
75239-005-17
75239-006-02
75239-006-03
75239-006-04
75239-006-05
75239-006-06
75239-006-07
75239-006-08
75239-006-09
75239-006-10
75239-006-11
75239-006-12
75239-006-13
75239-006-14
75239-006-15
75239-006-16
75239-006-17
75239-006-18
75239-006-19
75239-006-20
76687-005-02
76687-005-03
76687-005-04
76687-005-05
76687-005-06
76687-005-07
76687-005-08
76687-005-09
76687-005-10
76687-005-11
76687-005-12
76687-005-13
76687-005-14
76687-005-15
76687-005-16
76687-005-17
76687-005-18
76687-005-19
76687-005-20
76687-006-02
76687-006-03
76687-006-04
76687-006-05
76687-006-06
76687-006-07
76687-006-08
76687-006-09
76687-006-10
76687-006-11
76687-006-12
76687-006-13
76687-006-14
76687-006-15
76687-006-16
76687-006-17
76687-006-18
76687-006-19
76687-006-20
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a warning letter on 07/06/2021; product voluntarily recalled by Native Promotions, Inc. on 7/12/2021
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Cloudz instant hand sanitizer
74935-020-00
74935-020-01
79860-020-00
79860-020-01
Solaray, LLC (Oklahoma)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Artnaturals Hand Sanitizer Infused with Jojoba Oil
74935-016-00
74935-018-00
78706-016-00
78706-018-00
Artnaturals (California)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Orchard De Flore Instant Hand Sanitizer
74935-015-00
74935-015-01
78733-015-00
78733-015-01
Sonora Corp. (California)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Premium Nature Hand Sanitizer
74935-010-04
74935-010-08
Premium Nature (New Jersey)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Artnaturals Hand Sanitizer Scent Free
74642-002-00
74935-002-00
Artnaturals
(California)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Germ Free Anti-Bacterial Instant Hand Sanitizer
74935-003-00
76782-003-00
Blue Mineral Corporation
(New Jersey)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Purago Advanced Hand Sanitizer
74935-004-00
74935-012-00
76812-004-00
76812-009-00
Puraall, LLC
(Georgia)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
CB Advanced Hand Sanitizer
74935-005-00
74935-014-00
76813-005-00
76813-014-00
CB Distributors, Inc.
(Wisconsin)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Orchard De Flore Instant Hand Sanitizer
74935-006-00
74935-006-01
74935-006-02
74935-006-03
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
True Wash Instant Hand Sanitizer
74935-007-00
74935-007-01
74935-007-02
74935-007-03
75478-007-00
75478-007-01
75478-007-02
75478-007-03
Supply Chain Sources, LLC
(California)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Eluo Advanced Hand Sanitizer with Aloe
74935-008-00
76869-008-00
Titan TD, Inc
(California)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Apollo Instant Hand Sanitizer Anti Bacterial
74935-009-00
Apollo Distributors
(Texas)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
SureSafe Handsanitizer Gel with Aloe
74935-011-00
74935-011-01
78111-010-00
78111-010-01
JAB Holdings, LLC
(Hawaii)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Health & Wellness Essentials Hand Sanitizer Wash-Free
74935-017-00
Health & Wellness Essentials, Inc
(California)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
New Sanicol Advanced Antibacterial Hand Sanitizer
74935-019-00
79254-019-00
AM Beauty Distributors
(New York)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Uncle Jed’s Cold Remedy Hand Sanitizer
74935-021-01
81172-000-01
Earth Sense Energy Systems, Inc
(Wisconsin)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
EA Instant Hand Sanitizer
74935-013-00
74935-013-01
74935-013-02
74935-013-03
74935-013-04
78233-013-00
78233-013-01
78233-013-02
78233-013-03
78233-013-04
National Travel Products, Inc (New Jersey)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 5/16/2022; FDA issued a warning letter on 07/20/2022.
06/08/2022
76949-234-02
76949-235-01
76949-235-02
50302-013-60
50302-020-50
76766-001-02
76766-001-03
50302-003-11
50302-003-60
50302-021-50
76766-000-01
76766-000-02
76766-000-03
76766-002-02
76766-002-03
76766-002-04
77196-001-05
77196-001-06
77196-001-07
77196-001-08
77196-002-01
77196-002-02
77196-002-03
77196-002-04
77196-002-05
77196-002-06
77196-002-07
77196-002-08
77196-002-09
77196-002-10
71761-000-05
71761-000-10
71761-000-20
71761-000-22
71761-000-37
71761-000-99
76528-420-02
76528-420-03
76528-420-04
77271-001-02
77271-001-03
77271-001-04
77271-001-05
77271-001-06
77271-001-07
77271-002-02
77271-002-03
77271-002-04
77271-002-05
77271-002-06
77858-0751-1
77858-0752-1
77858-0755-1
77858-0755-2
78106-002-02
78106-002-03
78106-002-06
78106-002-07
77210-0012-2
77210-0012-3
77210-0012-4
77210-0013-1
76947-198-21
76947-199-21
65055-600-01
65055-600-02
73755-120-02
73755-120-04
73755-130-02
73755-200-02
75416-004-01
75416-378-04
76753-001-02
76753-001-03
Moisturizing Hand Sanitizer –
Mixed Berries Scented
Green Tea Scented 500mL
Hello Kitty Watermelon Scent
Hello Kitty Strawberry Scent
Eucalyptus Scented
Green Tea Scented 60mL
Green Tea Scented Towlettes
Hello Kitty Candy Apple Scent
Gudetama Peach Scent
75010-020-01
75010-030-01
75010-050-01
75010-060-01
75010-070-01
75010-080-01
75010-090-01
75010-110-01
75010-120-01
AOMI Hand Sanitizer Gel and Spray
75010-010-01
75010-040-01
75010-140-01
CoSo Health Hand Sanitizer
75010-100-01
TerraPure Hand Sanitizer
75010-150-01
75010-150-02
75010-150-03
Instant Hand Sanitizer
with natural extracts
Instant Hand Sanitizer Wipes
74443-010-15
74443-010-50
74443-020-05
74443-020-50
74443-030-01
74443-030-05
77106-001-02
77106-001-03
77106-001-04
77106-001-05
77106-001-06
77106-001-07
77106-001-08
75477-435-10
75477-435-12
75477-435-25
75477-435-50
75477-534-10
69912-008-02
69912-009-03
69912-009-04
69912-009-05
69912-009-06
75810-103-04
75810-103-05
74530-046-01
Kills Germs
74530-042-01
74530-041-01
74530-015-01
74530-015-02
74530-015-03
74530-015-04
74530-015-05
74530-015-06
74530-011-01
74530-011-02
74530-011-03
74530-011-04
74530-011-05
74530-011-06
74530-011-07
74530-011-08
74530-013-01
74530-013-03
74530-013-04
74530-013-05
74530-013-06
74530-013-07
74530-013-08
74530-013-02
74530-012-01
74530-012-03
74530-012-04
74530-012-05
74530-012-06
74530-012-07
74530-012-08
74530-012-02
Ningbo Pasco United Industry Co., Ltd. (China)
Pasco Instant Hand Sanitizer Aloe & Moisturizers
52903-001-01
52903-002-01
52903-003-01
52903-004-01
52903-005-01
52903-051-01
52903-052-01
52903-053-01
52903-054-01
52903-055-01
52903-100-01
52903-101-01
52903-201-01
52903-301-01
52903-401-01
52903-501-01
52903-501-91
52903-502-01
52903-502-91
The BIGBOND LLC
(New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Ningbo Pasco United Industry Co., Ltd. (China)
Pasco Alcohol Antiseptic 80%
Hand Rub
59203-500-01
The BIGBOND LLC
(New Jersey
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Ningbo Pasco United Industry Co., Ltd. (China)
Delma Instant Hand Sanitizer Gel
80208-111-01
80208-111-02
80208-111-03
80208-111-04
80208-111-05
Delma Global Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Ningbo Pasco United Industry Co., Ltd. (China)
Delma Instant Hand Sanitizer Gel
With Aloe Vera
80208-112-01
80208-112-02
80208-112-03
80208-112-04
Delma Global Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Ningbo Pasco United Industry Co., Ltd. (China)
Pasco Instant Hand Sanitizer Aloe & Moisturizers
87052-003-02
87052-004-01
87052-005-01
87052-005-02
87052-007-01
87052-008-01
87052-009-01
87052-010-01
87052-013-01
87052-111-01
87052-115-01
87052-117-01
87052-119-01
The BIGBOND LLC
(New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Ningbo Pasco United Industry Co., Ltd. (China)
Pasco Alcohol Antiseptic 80%
Hand Rub
80752-500-01
The BIGBOND LLC
(New Jersey)*
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
77031-454-34
77145-000-01
77145-000-02
77145-001-01
77145-001-02
77145-001-03
77145-002-03
76839-521-04
76839-522-03
75091-2020-2
75091-2020-3
78065-2020-2
76560-0001-3
76560-0001-4
76560-0001-5
76560-0001-6
76560-0001-8
76560-0002-2
76560-0002-3
73891-1001-5
73891-1002-4
73891-1002-5
77492-007-01
77492-008-50
77492-009-05
74844-162-08
74844-162-17
74844-162-34
74541-270-02
74541-270-04
74541-270-06
74541-270-08
74541-270-17
74541-270-34
74541-270-37
74844-165-08
74844-165-17
74844-165-34
74844-170-02
74844-170-08
74844-170-17
74844-170-34
76891-104-12
76891-104-13
76891-104-14
76891-104-15
76891-104-16
76891-104-17
76891-104-18
76891-104-19
73389-104-11
76891-105-12
76891-105-13
76891-105-14
76891-105-15
76891-105-16
76891-105-17
76891-105-18
76891-105-19
76891-105-20
75460-070-02
75460-070-05
74882-341-02
74882-341-03
74882-007-02
74882-007-03
S-One Pharmaceutical Inc
(Korea)
Safe Cleaner Hand Sanitizer Gel
Sophora Extract
Mint Oil
Grapefruit Extract
74721-0001-1
74721-0001-2
74721-0001-3
74721-0001-4
74721-0001-5
74721-0001-6
74721-0001-7
74721-0001-8
74721-0001-9
74721-0001-0
74721-0002-1
74721-0002-2
74721-0002-3
74721-0002-4
74721-0002-5
74721-0002-6
74721-0002-7
74721-0002-8
74721-0002-9
S-ONE Pharmaceutical Inc. (Korea)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022
06/29/2022
S-One Pharmaceutical Inc
(Korea)
Safe Cleaner K
Disinfection Spray Chlorine Dioxide Ion (1-)
74721-0050-1
S-ONE Pharmaceutical Inc. (Korea)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022
06/29/2022
S-ONE Pharmaceutical Inc. (Korea)
PFA Stronghold Moisturizing Sanitizing Hand Lotion (Mint, Shea Butter, Rose)
80969-006-01
80969-007-01
80969-008-01
Stronghold Trading, LLC
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022
06/29/2022
S-ONE Pharmaceutical Inc. (Korea)
PFA Protection For All Hand Sanitizer
80969-010-01
80969-010-02
80969-010-06
80969-010-07
80969-020-03
80969-020-04
80969-040-03
80969-040-04
Stronghold Trading, LLC
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022
06/29/2022
S-ONE Pharmaceutical Inc. (Korea)
PFA Stronghold Hand Sanitizer
Alcohol Free Disinfectant
80969-030-02
Stronghold Trading, LLC
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022
06/29/2022
S-ONE Pharmaceutical Inc. (Korea)
NYC HEALTH HOSPITALS HAND SANITIZER
80969-050-01
80969-050-02
Stronghold PFA
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022
06/29/2022
S-ONE Pharmaceutical Inc. (Korea)
Safe Cleaner Plus
Sophora Extract
Mint Oil
Grapefruit Extract
74721-0010-1
74721-0010-2
74721-0010-4
74721-0010-5
74721-0010-6
74721-0010-7
74721-0010-8
74721-0010-9
74721-0020-0
74721-0020-1
74721-0020-2
74721-0020-5
74721-0020-6
74721-0020-7
74721-0020-8
74721-0020-9
S-ONE Pharmaceutical Inc. (Korea)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 7/12/2022
06/29/2022
90032-214-83
90032-214-94
71120-112-01
71120-112-05
71120-112-06
71120-112-08
71120-112-10
71120-112-11
71120-611-07
71120-611-08
71120-612-06
71120-612-07
71120-117-02
71120-111-02
71120-111-03
75078-003-01
75078-004-01
86818-002-07
86818-002-08
86818-005-02
86818-005-03
86818-005-04
86818-005-05
86818-005-06
75821-001-01
75821-001-02
75821-001-03
75821-001-04
75821-002-01
75821-002-02
75821-002-03
200401143;
200406143;
200414145;
200415145;
200422145;
200522148;
200611145.
78247-005-05
78247-008-10
71693-007-01
70108-043-01
71693-008-01
70108-044-01
71693-004-01
70108-045-01
71693-005-01
70108-046-01
71693-006-01
70108-047-01
71693-009-01
64009-331-85
64009-331-88
75165-001-01
75165-003-02
75165-004-01
75165-005-01
75165-006-01
75165-250-01
79095-001-01
79095-002-01
79095-003-01
79095-004-01
79095-005-01
79095-006-01
(Iowa)
74560-001-02
74560-001-03
74560-001-04
74560-001-05
(Louisiana)
(Louisiana)
76676-402-02
76676-402-14
76676-402-09
76676-402-08
76676-402-11
76676-402-06
76676-402-12
76676-402-13
76676-402-17
76676-402-18
76676-402-19
True Chemical Solutions, LLC (Texas)
Hand Sanitizer B,
Hand Sanitizer C,
Hand Sanitizer E,
Hand Sanitizer G
77991-000-00
77991-001-00
77991-002-00
77991-003-00
Scent Free Hand Sanitizer Natural Elements + Cleansing Formula
8 fl oz (236ml)
76619-110-03
76619-110-04
76619-110-05
76619-110-06
76619-110-07
76619-110-08
76619-110-09
76619-120-02
74401-800-32
77991-004-01
77991-004-02
77991-004-03
77991-004-04
77991-004-05
77991-004-06
Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting
"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.
Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.
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