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FDAJuly 18, 2018drug

Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.

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

The hazard

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

What to do

FDA enforcement status: Terminated

Brands named

major pharmaceuticalsmajor

Recall history

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

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