FDA-Drug2022-06-08Class II
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
Direct Rx
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Sold states
AL, GA, FL, LA
Affected count
81 bottles
Manufactured in
94 Worldwide Dr, N/A, Dawsonville, GA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0971-2022Don't want to check this manually?
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