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November 27, 2018 – A sixth medication for hypertension, valsartan, was recalled due to the presence of impurities in its key ingredient.
Teva Pharmaceuticals announced Tuesday the nationwide recall of all amlodipine / valsartan combination tablets and all amlodipine / valsartan / hydrochlorothiazide tablets due to a problem related to the drug. 39; valsartan active ingredient manufactured in Mylan, India.
An impurity known as N-nitrosodiethylamine (NDEA) was found in Mylan valsartan. NDEA has been shown to cause cancer in humans.
The medications involved are used to treat high blood pressure. Teva says that no case of illness has been reported.
Patients taking these medications are urged to continue and contact their pharmacist or doctor for alternatives.
In July, the FDA announced the recall of five other valsartan products for NDEA contamination as well as possible contamination with a similar impurity, NDMA. Several other reminders were announced in August. An antihypertensive drug, based on irbesartan, was recalled earlier this month, as well as another against losartan.
All recalled products contain ingredients made in China or India. The sudden precipitation of recalls due to foreign-made ingredients has put greater vigilance on these foreign laboratories and on the ability of the FDA to effectively control the safety of their products.
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