FDAMarch 4, 2019drug

Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.

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

The hazard

CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).

What to do

FDA enforcement status: Terminated

Brands named

h j harkins company inc dba pharma pac

UPCs

7651910330331722070230

Recall history

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

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