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FDA reminds compounders to use ingredients suitable for sterile compou

by Pill Pals | Oct 30, 2024 | News

FDA is reminding compounders to only produce sterile drugs using components that are suitable for compounding drugs intended to be sterile. The agency is aware of compounders using food-grade nicotinamide adenine dinucleotide (NAD+) sold by repackagers to make...

Know Your Bulks and Excipients Suppliers

by Pill Pals | Oct 30, 2024 | News

Quality Matters Related to Components of a Drug FDA continues to identify several issues related to repackagers of bulk drug substances, also called active pharmaceutical ingredients (APIs), and excipients used to compound drugs that have resulted in patient harm. ...

Important Information on Use of Unapproved HIV Blood Sample Self-Kits

by Pill Pals | Oct 30, 2024 | News

October 29, 2024 Summary of the Issue: The Food and Drug Administration is advising the public, including consumers, health care professionals, and community-based organizations, health departments, and clinics where HIV self-testing programs are available, that HIV...

MedOffice Saglik Endustri Anonim Sirketi – 687586

by Pill Pals | Oct 29, 2024 | News

Delivery Method: VIA UPS Reference #: 320-25-07 Product: Drugs Recipient: Recipient Name Mr. Yucel Teker Recipient Title General Manager/Chairman of the Board MedOffice Saglik Endustri Anonim Sirketi Ic Kapi No. 1, No. 9-1 Yazibasi Mahallesi, Kuscu Caddesi35880...

Choice All Natural, Inc. dba Om Botanical – 685615

by Pill Pals | Oct 29, 2024 | News

Delivery Method: VIA UPS Reference #: 320-25-06 Product: Drugs Recipient: Recipient Name Mr. Sudhir Shah Recipient Title President Choice All Natural, Inc. dba Om Botanical 1019 Classic RoadApex, NC 27539-4402United States Issuing Office: Center for Drug Evaluation...

Update: Use of GE HealthCare EVair and EVair03 Compressors

by Pill Pals | Oct 29, 2024 | News

October 29, 2024 The U.S. Food and Drug Administration (FDA) is issuing this update to inform the health care community of a change in recommendations for the GE HealthCare EVair Compressor. Previously, on December 29, 2023, GE HealthCare issued an Urgent Medical...