CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
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 Ascend Laboratories, LLC to request your refund or repair — edit it as you like.
Subject: Recall D-0263-2021 — Ascend Laboratories, LLC Ascend Laboratories LLC recalls Cephalexin for Oral Suspension, USP 250 mg Hello, I own a Ascend Laboratories LLC recalls Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, that is covered by recall D-0263-2021 from Ascend Laboratories, LLC. 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.
