Coupler Enterprises – 607662 – 09/15/2020

by Pill Pals Customer Service | Mar 20, 2025 | News

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Wayne Shafer Coupler Enterprises 125 Titus Ave, Suite 200Warrington, PA 18976-2424United States wjshafer@contractpharmacy.com Issuing Office: Division of Pharmaceutical Quality Operations I United...

Early Alert: Aspiration System Issue from Calyxo

by Pill Pals Customer Service | Mar 20, 2025 | News

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes...

Dessert Holdings Issues Allergy Alert on Undeclared Tree Nut Allergen in Favorite Day™ Gourmet New York Style Cheesecake 6oz/2ct

by Pill Pals Customer Service | Mar 20, 2025 | News

Summary Company Announcement Date: March 19, 2025 FDA Publish Date: March 20, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Potential or Undeclared Allergen – Pecans Company Name: Dessert Holdings Brand...

Re-Gen Active Lab, Inc. – 620763

by Pill Pals Customer Service | Mar 20, 2025 | News

Delivery Method: VIA UNITED PARCEL SERVICE Product: Biologics Recipient: Recipient Name Martin M. Porter Recipient Title Chief Operating Officer Re-Gen Active Lab, Inc. 2216 W. Walnut Hill LaneIrving, TX 75038United States Issuing Office: Office of Biological Products...

Integrated Health Concepts Inc. dba Conversio Health – 610546

by Pill Pals Customer Service | Mar 20, 2025 | News

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Taylor Cline Integrated Health Concepts Inc. dba Conversio Health 720 Aerovista Place, Suite DSan Luis Obispo, CA 93401-8726United States Issuing Office: Division of Pharmaceutical Quality Operations...

Update on Alert: Atherectomy Catheter System Issue from Bard Peripher

by Pill Pals Customer Service | Mar 20, 2025 | News

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves updating the Instructions for using these devices and does not involve removing them from where they are used or sold. The FDA has identified this...

OsteoLife Biomedical I LLC – 626889

by Pill Pals Customer Service | Mar 20, 2025 | News

Delivery Method: VIA UPS Product: Biologics Recipient: Recipient Name Theodore I. Malinin, MD Recipient Title Medical Director and Co-Owner OsteoLife Biomedical I LLC 1951 NW 7th AvenueSanibel SuiteMiami, FL 33136United States Issuing Office: Office of Biological...

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy – 610384

by Pill Pals Customer Service | Mar 20, 2025 | News

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Dawn Hoang, R.Ph. First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy 6828 E. Brown Rd. Ste. 101Mesa, AZ 85207-3761United States Issuing Office: Division of Pharmaceutical Quality Operations...

Smart Surgical, Inc dba Burst Biologics – 614361

by Pill Pals Customer Service | Mar 20, 2025 | News

Delivery Method: VIA UNITED PARCEL SERVICE Product: Biologics Recipient: Recipient Name Mr. Christopher D. Jones Recipient Title Chief Executive Officer Smart Surgical, Inc dba Burst Biologics 3501 W. Elder St., Ste. 104Boise, ID 83705United States Issuing Office:...