Maquet Updates Use Instructions for Servo Ventilator Systems

by Pill Pals Customer Service | Jul 21, 2025 | News

This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it...

Integra Removes MicroMyst Applicators for Risk of Non-Sterile Product

by Pill Pals Customer Service | Jul 21, 2025 | News

This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.Affected ProductManufacturer’s Product Number (Catalog...

Nirwana Foods Issues Allergy Alert on Undeclared Sulfites on Golden Raisin 28Oz Pouch Label

by Pill Pals Customer Service | Jul 18, 2025 | News

Summary Company Announcement Date: June 28, 2025 FDA Publish Date: July 18, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared sulfites Company Name: Nirwana Foods LLC Brand Name: Product Description:...

International Activities

by Pill Pals Customer Service | Jul 18, 2025 | News

Image A critical component in how CBER carries out its regulatory responsibilities is through its international engagements. Many of the products CBER regulates directly address infectious disease threats which are not isolated to the U.S. CBER is also cognizant of...

SunMed Recalls Manual Resuscitator Due to Incorrect Assembly

by Pill Pals Customer Service | Jul 18, 2025 | News

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected ProductProduct Names: Adult Manual...

Regenerative Medicine Advanced Therapy Designation

by Pill Pals Customer Service | Jul 18, 2025 | News

As described in Section 3033 of the 21st Century Cures Act, a drug is eligible for regenerative medicine advanced therapy (RMAT) designation if: The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product,...