December 17, 2020
Ten lots of azacitidine for injection distributed by Celltrion USA Inc. are being voluntarily recalled by manufacturer Shilpa Medicare Limited. The December 16, 2020, US Food and Drug Administration (FDA) Enforcement Report cited deviations from good manufacturing practices as the reason for the recall.
The recall affects single-dose vials of azacitidine for injection, 100 mg/vial (NDC 72606-558-01 or NDC 72485-201-01), for subcutaneous and intravenous use only, from lots 7S10227A (Exp. 10/31/21); 7S10115A (Exp. 7/31/21); 7S10143A and 7S10182B (Exp. 9/30/21); 7S10185A (Exp. 10/31/21); 7S10255A, 7S10256A, and 7S10263A (Exp. 11/30/21); 7T10028A (12/31/21); and 7T10040A (Exp. 1/31/22). Celltrion USA distributed the vials throughout the United States.
Shilpa Medicare Limited initiated the recall November 17, 2020. On December 9, 2020, the FDA designated it Class II, signaling use of the drug may cause temporary or medically reversible adverse health consequences. Although remote, the possibility of serious harm also exists.
Azacitidine is a chemotherapy medication used to treat myelodysplastic syndromes, in which bone marrow fails to produce enough healthy blood cells.