FDA recall D-1463-2019

Golden State Medical Supply Inc. · Class II · drug

Product

Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90

Reason for recall

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Distribution

US Nationwide One (1) US government account. No foreign accounts.

Key facts

Status: Terminated
Initiation date: 2019-06-14
Report date: 2019-07-17
Termination date: 2020-02-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1463-2019