Drug product
Amphotericin B Liposome for Injection, 50mg vials, 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 62756-233-01
D-0493-2024
Product summary
- Event
- Event 94442
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11,016 vials
- Official record key
drug-enforcement:D-0493-2024
Official wording
Reason: Out of specification for assay
Code information: Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out of specification