Reported Feb 2, 2022 · Terminated

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01

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

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01

Lot codes and dates: M008130 06/2022
M008131 06/2022
M008132 06/2022
M008133 06/2022
M010080 07/2022
M010081 07/2022
M011029 08/2022
M011030 08/2022
M011031 08/2022
M011032 08/2022
M011304 08/2022
M013394 09/2022
M013395 09/2022
M013396 09/2022
M013966 09/2022
M013967 09/2022
M100831 12/2022
M100832 12/2022
M100833 01/2023
M100834 01/2023
M101267 01/2023
M102718 01/2023
M102719 01/2023
Amount recalled: 23,8416/100 count bottles

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.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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