FDA-Drug2022-06-01Class II
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
Direct Rx
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Sold states
FL
Affected count
6 bottles
Manufactured in
94 Worldwide Dr, Dawsonville, GA, United States
Products
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0894-2022Don't want to check this manually?
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