H J Harkins Company Inc dba Pharma Pac recalls Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear

Recalled April 17, 2019 · FDA recall D-1083-2019 · H J Harkins Company Inc

Hazard

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

Units

300 tablets

Sold at

Product was distributed to a physician's office in California.

Description

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

Product

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.

Manufacturer(s)

H J Harkins Company Inc dba Pharma Pac

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →