Class II
Terminated
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.
This recall has been terminated (originally issued December 16, 2020).
- Company
- Shilpa Medicare Limited
- Recall Initiated
- December 8, 2020
- Posted
- December 16, 2020
- Recall Number
- D-0121-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,064 vials
- Firm Location
- Polepally, Jadcherla, India
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations
Distribution
Nationwide in the U.S.
Lot / Code Info
Lot #: 7S10008B, Exp. 12/31/2020
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