Mylan has expanded the consumer-level voluntary recall of all lots of valsartan-containing drugs within expiry in the US after finding trace amounts of an impurity called N-nitrosodiethylamine (NDEA).
Valsartan is indicated to address high blood pressure for treating heart failure and to decrease cardiovascular mortality following myocardial infarction.
NDEA occurs naturally in some foods, drinking water, air pollution and industrial processes. The substance has been classified as a probable human carcinogen.
The nationwide recall by the company covers Valsartan Tablets, Amlodipine and Valsartan Tablets, and Valsartan and Hydrochlorothiazide Tablets.
Mylan initiated the recall last month for a total of 15 lots of the products, which has now been expanded to 104 additional lots. All the products have been manufactured by Mylan Laboratories.
Announcing the recall, Mylan said: “Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products.
“Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products. This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).”
Over the year, certain valsartan-containing drugs have been subjected to recall due to presence of impurities, including NDEA and N-nitrosodimethylamine (NDMA).
In July this year, UK and Irish regulatory authorities recalled all batches of valsartan-containing products following detection of NDMA. This included products manufactured by Dexcel Pharma and Accord Healthcare.
The FDA announced a similar move later that month in the US, recalling valsartan-containing drugs manufactured by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries.
In September, the European Medicines Agency (EMA) and the FDA identified the presence of a NDEA in valsartan products.