November 02, 2018
Sterility concerns have prompted Heritage Pharmaceuticals Inc. to issue a voluntary recall for cidofovir injection 375 mg/mL injection in 5-mL vials (NDC 23155-216-31), according to the October 31, 2018, US Food and Drug Administration (FDA) Enforcement Report. The recall follows customer complaints reporting dried powder on the outside of the bottle.
The recall affects 2789 units manufactured by Emcure Pharmaceutical from lot VCIA083 (Exp. 6/20). The products were distributed throughout the United States.
Heritage Pharmaceuticals initiated the recall October 15, 2018. On October 24, 2018, the FDA designated it Class II, signaling use of the affected vials could cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Cidofovir injection is a prescription antiviral drug used intravenously to treat eye infections caused by cytomegalovirus in patients with acquired immunodeficiency syndrome (AIDS).
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