Reported Jun 30, 2021 · Terminated

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare…

Viona Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: VIONA PHARMACEUTICALS INC · 20 Commerce Dr Ste 340 · Cranford, NJ · 07016-3617

Is this the product you have?

  • Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only
  • Manufactured byCadila Healthcare Ltd. Ahmedabad, India
  • Distributed byViona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01
Lot codes and dates
    • Lot M915601 & M915602
    • Oct 2021
Amount recalled
21240 bottles

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 31, 2023 · Data as of Sep 19, 8:04 PM UTC

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