FDA recall D-1083-2019

H J Harkins Company Inc dba Pharma Pac · Class II · drug

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.

Reason for recall

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2019-03-04
Report date: 2019-04-17
Termination date: 2023-05-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Grover Beach, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1083-2019