Why it was recalled
Subpotent drug
Product description
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
Lot numbers, UPCs & expiration codes
Lot # BAD0089A, Exp 01/2025; BAD0330A, Exp 07/2025
Where it was sold
USA nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0891-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 30, 2023
- FDA report date
- Jul 5, 2023
- Quantity
- 12960 vials
- Recall type
- N/A
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0891-2023, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92425
- Address
- 2 Independence Way
- Code information
- Lot # BAD0089A, Exp 01/2025; BAD0330A, Exp 07/2025
- Postal code
- 08540-6620
- Report date
- Jul 5, 2023
- Product type
- Drugs
- Recall number
- D-0891-2023
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 12960 vials
- Termination date
- Dec 18, 2023
- Reason for recall
- Subpotent drug
- Product description
- 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
- Distribution pattern
- USA nationwide
- Recall initiation date
- May 30, 2023
- Center classification date
- Jun 29, 2023