Why it was recalled
Out of specification for assay
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026
Where it was sold
Nationwide within the United States
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-0493-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 19, 2024
- FDA report date
- May 15, 2024
- Quantity
- 11,016 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0493-2024, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94442
- Address
- 2 Independence Way
- Code information
- Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026
- Postal code
- 08540-6620
- Report date
- May 15, 2024
- Product type
- Drugs
- Recall number
- D-0493-2024
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 11,016 vials
- Reason for recall
- Out of specification for assay
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Apr 19, 2024
- Initial firm notification
- Letter
- Center classification date
- May 8, 2024