Problems with N-nitrosodimethylamine (NDMA)-contaminated metformin were identified by the FDA in 2020. Viona Pharmaceuticals announced in earlier this month that it was recalling 23 lots of the popular diabetes medication.
N-nitrosodimethylamine (NDMA), a carcinogen, has been detected in metformin, before and that has led to recalls of a drug taken by millions to manage their type 2 diabetes.
Now it has happened again.
In the first drug recall of 2022, Cranford, New Jersey-based Viona Pharmaceuticals is voluntarily recalling 23 lots of metformin hydrochloride extended-release tablets, USP 750 mg, at the consumer level. The pharma maker shipped the metformin nationwide to distributors.
Viona found an out of specification (OOS) result for NDMA in one lot of the product. “In an abundance of caution, the firm has decided to voluntarily recall 23 batches, which we have determined having a valid shelf life within the US market,” Viona said.
The metformin in question was manufactured by Cadila Healthcare Limited in Ahmedabad, India.
Despite the recall, patients who have received the impacted lots are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment, Viona said.
“According to the FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals,” Viona said.
The metformin recalls began in early 2020, when the FDA said its testing found “certain extended release metformin products contain NDMA above the acceptable level.”
At that time, five major pharmaceutical manufacturers recalled their extended-release metformin tablets. Apotex, Amneal, Teva Pharamceuticals and Marksans Pharma Limited were among those issuing recalls.
Then, later that year, several other pharma makers followed suit with major metformin recalls.
For example, in October 2020, Marksans Pharma Limited in India is expanded its earlier initiated recall in June to include an additional 76 lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg to the consumer level.