Viona Pharmaceuticals Inc. has recalled type 2 diabetes drug Metformin in the form of oral film-coated tablets for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA), above levels of the Acceptable Daily Intake Limit (ADI), the U.S. Food and Drug Administration or FDA said in a statement.
The recall involves 2 lots each of Metformin HCl Extended Release tablets USP 750 mg. The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. These are packaged in HDPE bottles of 100 tablets.
The affected Metformin 750 mg tablets are with expiry date of October 2021. These drugs were distributed across the U.S. to wholesalers. They were manufactured by Ahmedabad, India-based Cadila Healthcare Ltd. in November 2019, for U.S. distribution by Viona Pharmaceuticals.
NDMA, a known environmental contaminant, is classified as a probable human carcinogen, a substance that could cause cancer. It is generally found in water and foods, including meats, dairy products, and vegetables.
The company said it has not received any reports of adverse events related to this recall to date.
Patients who have received impacted lots of Metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment. The company is arranging for return of all recalled products to its recall processor Eversana Life Science Services.
The FDA began testing Metformin in the U.S. supply after it become aware of NDMA in some Metformin products in other countries in late 2019. The FDA later urged many drug companies that manufacture Metformin to implement the drug’s recall due to NDMA impurity.
In January, Nostrum Laboratories, Inc. recalled one lot of Metformin Hydrochloride, in September last year, India-based Sun Pharmaceutical Industries, Inc. recalled one lot of type 2 diabetes medication RIOMET ER (metformin), and in July last year, India-based Lupin Pharmaceuticals Inc. called back all batches of Metformin.
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