FDA-Drug2019-04-17Class II
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.
H J Harkins Company Inc dba Pharma Pac
Hazard
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Sold states
Product was distributed to a physician's office in California.
Affected count
300 tablets
Manufactured in
1400 W Grand Ave Ste F, N/A, Grover Beach, CA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1083-2019Don't want to check this manually?
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