CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
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 AVKARE Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-1045-2019 — AVKARE Inc. AVKARE Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 Hello, I own a AVKARE Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only that is covered by recall D-1045-2019 from AVKARE 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.
