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
FDA recall notice · announced July 5, 2023 · Sun Pharmaceutical Industries
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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
Reason for recall
Subpotent drug
Notes
Distribution: USA nationwide
Lot/code information: Lot # BAD0089A, Exp 01/2025; BAD0330A, Exp 07/2025
Quantity: 12960 vials
Status: Terminated
Products in this recall event:
- 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, (D-0891-2023)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.