Nov. 27, 2018 — A sixth valsartan blood pressure drug has been recalled because of impurities in its key ingredient.
Teva Pharmaceuticals on Tuesday announced a nationwide recall of all amlodipine/valsartan combination tablets and all amlodipine/valsartan/ hydrochlorothiazide tablets due to a problem with the valsartan active ingredient manufactured in Mylan, India.
An impurity known as N-nitrosodiethylamine (NDEA) was found in Mylan’s valsartan. NDEA has been found to possibly cause cancer in humans.
The impacted drugs are used to treat high blood pressure. Teva says no reports of illnesses have been reported.
Patients taking these drugs are urged to continue and to contact their pharmacist or doctor for alternatives.
The FDA in July announced the recall of five other valsartan products for NDEA contamination as well as possible contamination from a similar impurity, NDMA. Several more recalls were announced in August, while an irbesartan-based blood pressure drug was recalled earlier this month, along with another made with losartan.
All of the recalled products have ingredients manufactured in either China or India. The sudden rush of recalls because of ingredients made overseas has put more scrutiny on these foreign labs and on the FDA’s ability to effectively monitor their products for safety.
WebMD Article Reviewed by Neha Pathak, MD on November 28, 2018
Sources
FDA.gov: “Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry.”
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