Compounded tirzepatide injections recalled over sterility concerns
A drug company in North Carolina is recalling some copies of the weight loss drug tirzepatide because it cannot be sure the shots are germ-free. Brand-name Mounjaro and Zepbound are not part of the recall. USA Today advised patients with a recalled lot to stop using it and call their doctor.
Apothecary Pharma is recalling compounded tirzepatide shots across the country because of a "lack of assurance of sterility," the Boston Globe, the Los Angeles Times and Quartz reported, citing the Food and Drug Administration. The company is a compounding pharmacy in Cary, North Carolina.
Tirzepatide is the active ingredient in the weight loss and diabetes drugs Mounjaro and Zepbound. Those brand-name shots are not affected by the recall, the Boston Globe reported.
The Boston Globe said the recall covers 22 lots. The Los Angeles Times and Quartz described it as 22 vials. The product is tirzepatide injection, 18 mg/mL, in 4 mL multi-dose vials, Quartz reported. The lot numbers run from AP-202622 to AP-202644. One vial of an NAD+ injection, lot AP-202647, is also part of the recall.
The company started the voluntary recall on Sept. 24 and sent letters to customers, Quartz reported, citing the FDA. On Oct. 8, the agency labeled it a Class II recall. That means the product may cause short-term health problems that can be reversed, the Los Angeles Times reported. The chance of serious harm is low.
The FDA did not say whether the recalled shots were contaminated, the Boston Globe reported. It also did not say what patients should do with their vials. USA Today advised patients with an affected lot to stop using it and to contact their prescriber, according to Quartz.
The FDA had earlier warned the company over "serious deficiencies" in how it makes drugs meant to be sterile, the Los Angeles Times and Quartz reported. The agency said those problems "put patients at risk."
Compounded drugs are custom versions mixed by pharmacies, the Los Angeles Times reported. They do not go through FDA review for safety or quality. Many pharmacies began making cheaper GLP-1 copies during a shortage that began in 2022. The FDA has warned patients to use these copies only when an approved drug cannot meet their needs, Quartz reported.
The FDA and Apothecary Pharma did not respond to requests for comment, the Boston Globe reported.
What we know: Apothecary Pharma is recalling compounded tirzepatide and one NAD+ vial over sterility concerns.
What we don't: Whether any recalled vials were contaminated, or whether any patients were harmed.
Where outlets agree The Boston Globe, the Los Angeles Times and Quartz all report that Apothecary Pharma is recalling compounded tirzepatide injections over a lack of assurance of sterility.
Where they differ The cited reports agree on the key facts so far.