Why it was recalled
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Product description
Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41
Lot numbers, UPCs & expiration codes
Lot#: 1203A, Exp. 5/11/2024
Where it was sold
Nationwide USA
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-0327-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 3, 2023
- FDA report date
- Feb 22, 2023
- Quantity
- 31,879 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Leadiant Biosciences, Inc.
Original FDA data
Every field from FDA enforcement report D-0327-2023, exactly as published.
Show all FDA fields
- City
- Gaithersburg
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 91643
- Address
- 9841 Washingtonian Blvd Ste 500
- Code information
- Lot#: 1203A, Exp. 5/11/2024
- Postal code
- 20878-7352
- Report date
- Feb 22, 2023
- Product type
- Drugs
- Recall number
- D-0327-2023
- Classification
- Class II
- Recalling firm
- Leadiant Biosciences, Inc.
- Product quantity
- 31,879 vials
- Termination date
- Sep 30, 2024
- Reason for recall
- Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Feb 3, 2023
- Initial firm notification
- Center classification date
- Feb 15, 2023