Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
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 Caraco Pharmaceutical Laboratories, Ltd. to request your refund or repair — edit it as you like.
Subject: Recall D-1407-2014 — Caraco Pharmaceutical Laboratories, Ltd. Caraco Pharmaceutical Laboratories, Ltd. recalls Gemcitabi Hello, I own a Caraco Pharmaceutical Laboratories, Ltd. recalls Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, that is covered by recall D-1407-2014 from Caraco Pharmaceutical Laboratories, Ltd.. 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.
