FDA recall D-1284-2019

Product

Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS Incorporated

Reason for recall

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Distribution

IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.

Key facts

Status

Terminated

Initiation date

2019-05-01

Report date

2019-05-29

Termination date

2020-02-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1284-2019