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GLP-1 injections recalled nationwide. See affected products
USA Today • • business
Key Points:
- Apothecary Pharma LLC has recalled 22 vials of compounded tirzepatide injections nationwide due to concerns over sterility, following an FDA warning about serious deficiencies in the pharmacy's sterile drug production practices.
- The FDA classified the recall as "Class II," indicating the medication could cause temporary or medically reversible adverse health consequences, though the risk of serious harm is considered small.
- Compounded GLP-1 injections like these are custom-formulated by compounding pharmacies and are not FDA-approved, raising ongoing safety concerns due to lack of routine FDA evaluation and past contamination incidents.
- Despite tirzepatide and semaglutide being removed from the official drug shortage list, many compounding pharmacies have continued producing these drugs, prompting FDA warnings and legal actions from pharmaceutical companies.
- Patients with affected lots are advised not to use the injections and to contact their prescribers for guidance, as no official public instructions on handling the recalled medication have been issued yet.
