GLP-1 weight-loss drug recall issued over contamination concerns

Summarised from 2 outlets · Updated 21 Oct, 21:57 · Archive

A nationwide recall has been issued for compounded tirzepatide and NAD+ injections over sterility concerns.

Apothecary Pharma, a North Carolina-based compounding pharmacy, voluntarily recalled 22 vials of compounded tirzepatide and one NAD+ injection vial on 24 September over concerns that the products may not be sterile. The FDA classified the recall as Class II on 8 October. Tirzepatide is the active ingredient in Eli Lilly's weight-loss drug Zepbound and diabetes medication Mounjaro, though the brand-name drugs themselves are not affected. The recalled products are compounded versions distributed nationwide, including through telehealth providers.

The New York Post reports that Apothecary Pharma had already received a warning letter from the FDA in December following an inspection that found 'serious deficiencies' in sterile drug production practices. The inspection identified operators improperly handling sterile containers, touching sterile work areas, failing to change gloves and using visibly rusty equipment. Both outlets note that a Class II recall means the products could cause temporary or medically reversible health consequences, though the risk of serious harm is considered low.

Anyone with a recalled product should stop using it and contact their pharmacist or healthcare provider. Those who develop a fever, redness, swelling or worsening pain after receiving an affected injection should seek medical attention. People who purchased these medications should check their vial labels for the manufacturer and lot number to determine if they are affected.

How it is being reported

• GLP-1 drug distributed nationwide under recallAnyone who has purchased the affected products should stop using them and contact their pharmacist or health care provider for adviceIndependent World · 21 Oct, 21:32
• GLP-1 injections recalled nationwide — what to know about the affected productsThe US-based pharmacy that issued the initial recall had previously received a warning.New York Post · 20 Oct, 16:05

In this story: Apothecary Pharma · FDA · Eli Lilly · North Carolina

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