Drug product
Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01
D-0891-2023
Product summary
- Event
- Event 92425
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12960 vials
- Official record key
drug-enforcement:D-0891-2023
Official wording
Reason: Subpotent drug
Code information: Lot # BAD0089A, Exp 01/2025; BAD0330A, Exp 07/2025
Distribution pattern: USA nationwide
Derived failure modes
-
Potency or specification failure
Subpotent