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FDAJanuary 10, 2019drug

Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.

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

The hazard

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

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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