STORY FROM: Drugs & Medical Devices

Teva Recalls Valsartan-Containing Drugs, Citing NDEA Contamination

WASHINGTON, D.C. — Teva Pharmaceuticals has initiated a voluntary recall of all lots of valsartan-containing drugs due to N-nitrosodiethylamine (NDEA) contamination, according to a Food and Drug Administration announcement.

Teva announced the recall on Nov. 27, which involves all lots of amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets due to an impurity detected above specification limits in an active pharmaceutical ingredient manufactured by Mylan India.

Teva is notifying its distributors and customers by letter and is arranging for return of all recalled products. Wholesalers, retailers and consumers that are in possession of recalled product should immediately stop distribution and ...

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