CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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 Appco Pharma LLC to request your refund or repair — edit it as you like.
Subject: Recall D-0648-2020 — Appco Pharma LLC Appco Pharma LLC recalls Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Ma Hello, I own a Appco Pharma LLC recalls Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, that is covered by recall D-0648-2020 from Appco Pharma 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.
