Viona Pharmaceuticals recalls Metformin Hydrochloride Extended-Release Tablets (750mg) due to detected N-Nitrosodimethylamine (NDMA) levels above acceptable limits. Consumers should stop using affected batches.
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets (750mg) because testing found N-Nitrosodimethylamine (NDMA) levels exceeding safe limits. This could pose a health risk with long-term use, so affected consumers should stop using the product immediately.
NDMA is a potential carcinogen that can form in some medications during manufacturing. The recall occurs because levels of this compound in the affected tablets exceed the acceptable daily intake limit, which could pose health risks with long-term use.
People who own or use the recalled Metformin Hydrochloride Extended-Release Tablets (750mg) in the specified batch numbers and dates. Those with diabetes who take this medication are most at risk.
Check for the product name 'Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles' with the NDC number 72578-036-01. Affected batches include specific model numbers and dates listed in the recall notice.
Immediately stop using the recalled Metformin Hydrochloride Extended-Release Tablets (750mg) if you have them.
Yes, the recall is due to detected N-Nitrosodimethylamine (NDMA) levels exceeding safe limits, which could pose health risks with long-term use.
Stop using the product immediately and contact Viona Pharmaceuticals for further instructions.
Check the product label for the NDC number 72578-036-01 and the specific batch numbers and dates listed in the recall notice.
We’ve drafted a message you can send Viona Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0392-2022 — Viona Pharmaceuticals Viona Pharmaceuticals Hello, I own a Viona Pharmaceuticals that is covered by recall D-0392-2022 from Viona Pharmaceuticals. 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.
