Docetaxel Injection USP 160 mg/ recalled over manufacturing violations
- Recall date
- December 8, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- 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…
- Recall number
- D-0126-2021
- FDA classification
- Class II
- Brand / firm
- Shilpa Medicare Limited
- Sold / distributed
- Nationwide in the U.S.
Why it was recalled
CGMP Deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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