CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
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 The Harvard Drug Group to request your refund or repair — edit it as you like.
Subject: Recall D-1360-2020 — The Harvard Drug Group The Harvard Drug Group recalls Metformin Hydrochloride Extended-Release Tabl Hello, I own a The Harvard Drug Group recalls Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, that is covered by recall D-1360-2020 from The Harvard Drug Group. 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.
