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FDA recalls lots of epoetin alfa due to glass in vials
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Amgen and the FDA have notified health care professionals that specific lots of epoetin alfa —Epogen and Procrit — have been recalled due to the possible detection of thin glass flakes in the vials that contain the product.
The notification came in the form of recall letters containing instructions for returning the referenced product to the returned goods service provider.
The warning precautions against potential serious adverse events that may occur. Particles delivered via the IV route may induce embolic, thrombotic and other vascular events, including phlebitis. Subcutaneous injection of the contaminated drug may lead to foreign body granuloma, local injection site reactions and increased immunogenicity.
Epoetin alfa is indicated for the treatment of anemia associated with HIV therapy, chronic renal failure and chemotherapy. Interaction between the drug and glass vials during shelf life may have caused the glass particles to become present in the product.
Information on recalled lot numbers and expiration dates can be found on the FDA website. Health care professionals are encouraged to report adverse events to the MedWatch Safety Information and Adverse Event Reporting Program.
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