Abelcet Injectable Drug Recalled Due to Bacterial Contamination
A sterile injectable drug, Abelcet, is being recalled due to bacterial contamination detected in a nationwide shipment. The recall affects 31,879 vials with lot number 1203A.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall is rated High because it involves a risk-of-harm product (injectable medication) with documented bacterial contamination but no reported illnesses or injuries at the time of recall. The FDA classified it as Class II.
Plain-English summary
Leadiant Biosciences, Inc. is recalling Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL vials distributed nationwide due to a sterility assurance failure. The affected lot is 1203A, which expires May 11, 2024.
Testing revealed the presence of Cupriavidus pauculus bacteria in the product. This bacterial contamination in an injectable medication poses a risk of infection if administered.
The recall affects 31,879 vials that were distributed nationwide. Healthcare providers and dispensers who have received this lot should stop dispensing and quarantine remaining vials. Patients who may have received an injection from this lot should contact their healthcare provider.
The recalled product
- Product
- 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
- Manufacturer
- Leadiant Biosciences, Inc.
- Category
- Drug
- Hazard
- bacterial-contamination
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: 1203A
- Exp. 5/11/2024
Distribution
Distributed nationwide across the United States.
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