CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
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 Mylan Pharmaceuticals Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-0792-2020 — Mylan Pharmaceuticals Inc. Mylan Pharmaceuticals Inc. recalls Nizatidine Capsules, USP 300 mg, Rx O Hello, I own a Mylan Pharmaceuticals Inc. recalls Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93. that is covered by recall D-0792-2020 from Mylan Pharmaceuticals 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.
