Leadiant Biosciences recalls Abelcet (Amphotericin B Lipid Complex) injection due to potential contamination with Cupriavidus pauculus. This may cause infection in patients receiving the medication.
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Leadiant Biosciences is recalling Abelcet (Amphotericin B Lipid Complex) injections because they may contain Cupriavidus pauculus, a bacterium that could cause infections. This recall affects patients using the medication under a prescription.
The injection may contain Cupriavidus pauculus, a bacterium that can lead to infections. This contamination risk is specific to the medication's sterility during manufacturing.
Patients prescribed Abelcet injections by a healthcare provider. Those with compromised immune systems are at higher risk of infection.
Check for the product name 'Abelcet', strength 5 mg/mL, 100 mg vial, and prescription-only status. The lot number 1203A and expiration date 5/11/2024 are also associated with this recall.
Verify the product name, strength, and lot number to confirm if it is part of this recall.
The recall indicates a potential contamination risk, so it is not safe to use without confirming the product is not recalled.
Check the product name, strength, lot number, and expiration date as listed in the recall notice.
The recall does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send Leadiant Biosciences to request your refund or repair — edit it as you like.
Subject: Recall D-0327-2023 — Leadiant Biosciences Leadiant Biosciences Hello, I own a Leadiant Biosciences that is covered by recall D-0327-2023 from Leadiant Biosciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
