FDAFDA · Food and drugs·Recall number D-0121-2021
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.
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 #: 7S10008B, Exp. 12/31/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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