FDA recall D-0893-2022

Direct Rx · Class II · drug

Product

Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

Reason for recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

Distribution

Key facts

Status: Terminated
Initiation date: 2022-05-11
Report date: 2022-06-01
Termination date: 2022-12-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0893-2022