Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.
Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Gilead Sciences, Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-821-2013 — Gilead Sciences, Inc. Gilead Sciences, Inc. recalls AmBisome (amphotericin B) liposome for Injection Hello, I own a Gilead Sciences, Inc. recalls AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, that is covered by recall D-821-2013 from Gilead Sciences, Inc.. 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.
