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Wednesday, July 28, 2021

Viona Pharmaceuticals Inc., Recalls Metformin HCl Extended-Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Viona Pharmaceuticals Inc. recalled 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the consumer level due to elevated levels of NNitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit.

According to the Food and Drug Administration (FDA), NDMA is classified as a potential human carcinogen, a substance that could cause cancer. 

Metformin Hydrochloride Extended-Release Tablets are used as a supplement to diet and exercise to improve blood sugar level in adults and pediatric patients with type 2 diabetes mellitus.

Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750 mg were distributed by Time-Cap Labs, Inc. nationwide.

Viona Pharmaceuticals Inc. encourages patients that are taking the recalled medications to continue taking them and to contact their local pharmacist, physician or medical provider for advice regarding an alternative treatment. 

There have been no reports of adverse reactions due to the recalled products thus far.

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