December 17, 2020
Deviations from good manufacturing practices have caused Shilpa Medicare Limited to recall 2008 vials of docetaxel injection distributed in the United States by Armas Pharmaceuticals Inc., according to the December 16, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects docetaxel injection, 160 mg/8 mL (20 mg/mL), for intravenous infusion only, 8-mL single-use vials (NDC 72485-216-08), from lot 7S10185A (Exp. 10/31/21).
Shilpa Medicare Limited voluntarily initiated the recall November 17, 2020. The FDA designated the recall Class II on December 9, 2020. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Docetaxel is a chemotherapy medication used to treat breast, lung, and other types of cancer.