Nostrum Laboratories recalls lots of metformin tablets after nitrosamine detection

Company is the latest in a lengthening list of pharma companies recalling the diabetes medicine over unacceptable levels of NDMA

The Missouri-based company said it is recalling two lots of 750 mg metformin HCl extended release tablets, which were found to contain levels of N-Nitrosodimethylamine (NDMA) above the US Food and Drug Administration’s ADI limit of 96 ng/day.

NDMA, a chemical form of nitrosamine, is classified as a probable human carcinogen and a possible cause of cancer.

Nostrum said it has not received any reports of adverse events related to the recall. It added it is notifying its distributors by letter and is arranging for return of all recalled products.

The case in the latest in a series of metformin recalls due to the presence of nitrosamine by pharmaceutical companies, including Amneal, Lupin and Marksans.

Metformin is used to treat type II diabetes and is designed to lower glucose levels.

Nitrosamines are genotoxic substances which may increase the risk of cancer in people exposed to above acceptable levels over longer periods of time. The issue of contamination in pharmaceutical products first arose in 2018 when the FDA detected impurities in Angiotensin II receptor blockers (ARBs).

Soon after, several ‘sartan’ medicines were also found to include nitrosamine impurities, leading to product recalls and a new set of manufacturing requirements for those medicines.

And most recently, the European Medicine Agency’s Committee on Human Medicinal Products said it was asking marketing authorization holders for medicines containing metformin – an oral drug used to control high blood sugar in patients with type II diabetes -- to test their medicines for nitrosamine before releasing them onto the market.