Recalls / Class II
Class IID-0891-2023
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
- Affected lot / code info
- Lot # BAD0089A, Exp 01/2025; BAD0330A, Exp 07/2025
Why it was recalled
Subpotent drug
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Notification channel
- N/A
- Type
- N/A
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 12960 vials
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2023-05-30
- FDA classified
- 2023-06-29
- Posted by FDA
- 2023-07-05
- Terminated
- 2023-12-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0891-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.