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FDADecember 4, 2018drug

Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5807-93.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

What to do

FDA enforcement status: Ongoing

Brands named

mylan laboratories limited nashik fdfmylanmylan laboratories

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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