Shilpa Medicare Limited recalls Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotox
Recalled December 16, 2020 · FDA recall D-0122-2021 · Shilpa Medicare
Hazard
CGMP Deviations · FDA Class II
Units
35,931 vials
Sold at
Nationwide in the U.S.
Description
CGMP Deviations
Product
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01.
Manufacturer(s)
Shilpa Medicare Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →