Drug product
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.
D-0121-2021
Product summary
- Event
- Event 86749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,064 vials
- Official record key
drug-enforcement:D-0121-2021
Official wording
Reason: CGMP Deviations
Code information: Lot #: 7S10008B, Exp. 12/31/2020
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations