August 25, 2017
Amgen Inc. is recalling more than 175,000 vials of Procrit (epoetin alfa) after glass flakes identified as lamellae were discovered in some of the vials, according to the August 23, 2017, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects Procrit 40,000 units/mL single-use vials (NDC 59676-340-01) for intravenous or subcutaneous use from lots G290491A and G290491B, which have an expiration date of June 2018.
The vials were distributed in the United States, including Puerto Rico.
Amgen initiated the voluntary recall August 4, 2017. On August 14, 2017, the FDA designated it Class II, indicating use of the affected product could cause temporary or medically reversible health consequences but that the probability of serious harm is remote.
Procrit is a prescription drug used to treat patients with anemia caused by chronic kidney disease or chemotherapy, or by taking the antiretroviral medication zidovudine.