Mylan Recalls Valsartan-Containing Drugs, Citing NDEA Contamination

WASHINGTON, D.C. — Mylan has initiated a voluntary recall of 15 lots of valsartan-containing drugs due to N-nitrosodiethylamine (NDEA) contamination, according to a Food and Drug Administration announcement.

On Nov. 20, Mylan announced the recall, which involves six lots of amlodipine and valsartan tablets (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of valsartan tablets (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of valsartan and hydrochlorothiazide tablets, 320mg/25mg strength.

The drugs are manufactured by Mylan Pharmaceuticals Inc. and Mylan Laboratories Limited, and the batches at issue were distributed in the United …