Product: Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
Reason for recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated: 20220505
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated