FDA/CDC

Teva recalls valsartan-containing combo pills


 

Teva Pharmaceuticals has issued a voluntary recall of all unexpired lots of amlodipine/valsartan and amlodipine/valsartan /hydrochlorothiazide combination tablets because of contamination with N-nitrosodiethylamine (NDEA), according to a company announcement posted on the website of the Food and Drug Administration.

FDA icon

The contaminant was detected at above acceptable limits in the valsartan component of the pills, which were manufactured by Mylan India. Mylan has already recalled its own valsartan-containing products. Teva has recalled other valsartan-containing products in recent months because of the presence of N-nitrosodimethylamine (NDMA).

Teva has now recalled all of its unexpired valsartan-containing products from the U.S. market. The Teva recall affects almost 50 lots, all distributed nationwide to Teva’s direct accounts, which include wholesalers, retailers, repackagers, Veterans Affairs pharmacies, and others. The lot and National Drug Code numbers of the affected products, as well as the company’s announcement, are available on the Food and Drug Administration website.

Teva is notifying its U.S. customers by certified mail and arranging for returns and reimbursements. Distribution of recalled products should stop immediately, the company said.

Patients, however, should contact their pharmacists or physicians for alternative options before stopping treatment. “The risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any comparable alternative treatment,” Teva said in its announcement.

The company plans regular updates as it works through the problem. NDEA is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes.

Questions and other concerns can be directed to Teva directly at 888-838-2872 or via email to druginfo@tevapharm.com.

Next Article: