CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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 Nostrum Laboratories, Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-0068-2021 — Nostrum Laboratories, Inc. Nostrum Laboratories Inc recalls Metformin Hydrochloride Extended-Releas Hello, I own a Nostrum Laboratories Inc recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum that is covered by recall D-0068-2021 from Nostrum Laboratories, 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.
