Drug 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.
D-0126-2021
Product summary
- Event
- Event 86749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2008 vials
- Official record key
drug-enforcement:D-0126-2021
Official wording
Reason: CGMP Deviations
Code information: Lot #: 7S10185A, Exp. 10/31/2021
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations