The US FDA is recommending a voluntary recall of certain extended release versions of metformin after testing revealed excessive levels of NDMA in some of these products. Metformin is the most commonly prescribed drug to treat type 2 diabetes.
The NDMA contaminant has the potential to be carcinogenic if there is exposure to above acceptable levels over long term use. This recall does not apply to immediate release metformin products, and the agency recommends that clinicians continue to prescribe metformin when clinically appropriate.
The FDA is contacting 5 pharmaceutical firms in particular as posted on the agency’s website, and is recommending that the companies voluntarily recall these products one of which listed on the agency’s site is Apotex Corp and its metformin hydrochloride ER USP 500 mg tablets.
