Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Singl...
FDA Recall #D-0126-2021 — Class II — December 8, 2020
Product Description
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.
Reason for Recall
CGMP Deviations
Recalling Firm
Shilpa Medicare Limited — Polepally, Jadcherla, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2008 vials
Distribution
Nationwide in the U.S.
Code Information
Lot #: 7S10185A, Exp. 10/31/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated