Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
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 Teva Pharmaceuticals USA, Inc to request your refund or repair — edit it as you like.
Subject: Recall D-928-2013 — Teva Pharmaceuticals USA, Inc Teva Pharmaceuticals USA, Inc. recalls CARBOplatin Injection, 600 mg/6 Hello, I own a Teva Pharmaceuticals USA, Inc. recalls CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC that is covered by recall D-928-2013 from Teva Pharmaceuticals USA, 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.
