Busulfan Injection 60 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 Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial,…
- Recall number
- D-0121-2021
- 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
Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, Vial NDC 72485-210-01, Carton NDC 72485-210-08.
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