Recall: D-0971-2022

Class II - Potentially Harmful

Class IIClassification

2022-05-05Initiated

TerminatedStatus

Direct RxFirm

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

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

Distribution

AL, GA, FL, LA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.