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 →