Mylan expands nationwide voluntary recall of valsartan-containing products

Mylan NV said it is expanding its consumer-level voluntary recall to include all lots of valsartan-containing products within expiry. The 104 additional lots are being recalled "out of an abundance of caution," Mylan said, after trace amounts of N-nitrosodiethylamine (NDEA), a probable cancer-causing impurity, were detected in the API valsartan.

Mylan NV said it is expanding its consumer-level voluntary recall to include all lots of valsartan-containing products within expiry. The 104 additional lots are being recalled "out of an abundance of caution," Mylan said, after trace amounts of N-nitrosodiethylamine (NDEA), a probable cancer-causing impurity, were detected in the API valsartan. The batches were distributed in the United States between March 2017 and November 2018. The expanded recall includes 26 lots of amlodipine and valsartan tablets, USP (including the 5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg, and 10 mg/320 mg strengths), 51 lots of valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and 27 lots of valsartan and hydrochlorothiazide tablets, USP (80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg strengths).