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

Recall Number: D-0893-2022

Firm: Direct Rx

Classification: Class II

Status: Terminated

Report Date: 20220601

Initiation Date: 20220511

Termination Date: 20221202

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

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