Viona Pharmaceuticals recalls 750mg Metformin Extended-Release Tablets (NDC 72578-036-01) due to detected N-Nitrosodimethylamine (NDMA) levels above safe limits. This medication is prescription-only.
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Viona Pharmaceuticals is recalling prescription Metformin Hydrochloride Extended-Release Tablets (750mg) manufactured by Cadila Healthcare. The recall is due to N-Nitrosod: a chemical found in excess of safe limits that could pose health risks with long-term use.
N-Nitrosodimethylamine (NDMA) is a chemical that can form in some medications during manufacturing. When detected in excess of safe limits, it may pose health risks with long-term use, though the risk level is considered low for this specific product.
Prescription patients who received Metformin Hydrochloride Extended-Release Tablets (750mg) with NDC 72578-036-01, Lot M915601 or M915602, manufactured in October 2021. Patients on diabetes medication are most at risk.
Check your prescription label for 'Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only'. Look for NDC code 72578-036-01 and lots M915601 or M915602 from October 2021.
Verify your prescription label matches the recalled product description and NDC code.
The recall is due to detected N-Nitrosodimethylamine (NDMA) levels above safe limits, but the risk level is considered low for this specific product.
Check your prescription label for 'Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only' with NDC 72578-036-01 and lots M915601 or M915602 from October 2021.
The recall does not specify a remedy, so contact your healthcare provider for guidance on whether to continue using the medication.
We’ve drafted a message you can send Viona Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0640-2021 — Viona Pharmaceuticals Viona Pharmaceuticals Hello, I own a Viona Pharmaceuticals that is covered by recall D-0640-2021 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.
