WASHINGTON — The manufacturer of common drugs used to treat blood pressure issues has issued a voluntary recall, according to the Food and Drug Administration.
Teva Pharmaceuticals said all lots of Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets are being voluntarily recalled due to an impurity detected above specification limits in an active ingredient manufactured by Mylan India.
“The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes,” the FDA said on its website.
The aforementioned tablets are used to treat high blood pressure.
“To date, Teva has not received any reports of adverse events signaling a potential link or exposure to valsartan,” the FDA said.
Additionally, patients were advised to continue taking the combination tablets and contact their pharmacist or physician for advice on an alternative treatment.
“The risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any comparable alternative treatment,” the FDA said.
Teva is notifying patients of the issue and arranging for return and reimbursement of affected pills.
Patients can contact Teva’s Medical Information team by phone at: 888-838-2872, option 3, then, option 4. Live calls are received Monday through Friday, 7 a.m. until 3 p.m. Mountain Time with voicemail available 24 hours a day. Patients can also email email@example.com.
In August, the FDA issued a mandatory recall on valsartan.