Shilpa Medicare Limited recalls Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic A
Recalled December 16, 2020 · FDA recall D-0126-2021 · Shilpa Medicare
Hazard
CGMP Deviations · FDA Class II
Units
2008 vials
Sold at
Nationwide in the U.S.
Description
CGMP Deviations
Product
Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72485-216-08.
Manufacturer(s)
Shilpa Medicare Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →