Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP recalled over manufacturing violations

Recall date

March 4, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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…

Recall number

D-1083-2019

FDA classification

Class II

Brand / firm

H J Harkins Company Inc dba Pharma Pac

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.