Recall: D-0893-2022
Class II - Potentially Harmful
Class IIClassification
2022-05-11Initiated
TerminatedStatus
Direct RxFirm
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
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Distribution
FL
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.