FDA-Drug2020-12-16Class II
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.
Shilpa Medicare Limited
Hazard
CGMP Deviations
Sold states
Nationwide in the U.S.
Affected count
2008 vials
Manufactured in
S-20 To S-26, Pharm. Formulation Sez, Tsiic, Green Industrial Park, Polepally, Jadcherla, N/A, India
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0126-2021Don't want to check this manually?
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