CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected 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 PD-Rx Pharmaceuticals, Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-1307-2020 — PD-Rx Pharmaceuticals, Inc. PD-Rx Pharmaceuticals, Inc. recalls metFORMIN HCL ER USP 500 mg, a) 30 Hello, I own a PD-Rx Pharmaceuticals, Inc. recalls metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: that is covered by recall D-1307-2020 from PD-Rx 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.
