(Reuters) – The U.S Food and Drug Administration said on Wednesday it had found high levels of a possible cancer-causing impurity in some versions of the popular diabetes drug metformin.
The agency is reaching out to companies whose drugs had N-nitrosodimethylamine (NDMA) over accepted levels and will take appropriate action, a spokesman for the FDA said in an emailed statement.
Bloomberg, which first reported the FDA’s findings, said that some recalls of metformin were expected as soon as this week, citing a person familiar with the matter.
Online pharmacy Valisure said in March that its independent tests showed high levels of NDMA in metformin made by 11 companies, including Amneal Pharmaceuticals Inc (AMRX.N) and Aurobindo Pharma Ltd (ARBN.NS).
In December, the FDA had started an investigation into metformin, a drug is used as an initial treatment for patients with type 2 diabetes.
NDMA contamination was responsible for the recall of heartburn drug Zantac sold by Sanofi SA (SASY.PA) last year and some generic versions of the treatment last year.
MAY 28, 2020