FDA recall D-0018-2021

Product

Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30

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 per manufacturer

Distribution

GA

Key facts

Status

Terminated

Initiation date

2019-04-30

Report date

2020-10-14

Termination date

2020-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0018-2021