FDAFDA · Food and drugs·Recall number D-0126-2021
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.
Published December 16, 2020 · Recall initiated: December 8, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Shilpa Medicare Limited
- Distributor
- Nationwide in the U.S.
- Lot
- Lot #: 7S10185A, Exp. 10/31/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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