April 20, 2018
InvaGen Pharmaceuticals Inc. is recalling 3222 vials of decitabine for injection (NDC 69097-285-37) after tested samples failed to meet impurity specifications, according to the April 18, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recalled 50-mg vials are from lots GE70493, GE70502, GE70512, all of which have an expiration date of August 2019. The decitabine vials were manufactured for Cipla USA Inc. by Cipla Ltd. and were distributed in the United States.
InvaGen Pharmaceuticals voluntarily issued the recall March 5, 2018. At press time, the FDA had not yet classified the recall.
Decitabine for injection is a prescription medication used to treat patients with myelodysplastic syndromes, or specific cancers that affect bone marrow and blood.
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