Product Safety Recalls

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HYDROCHLOROTHIAZIDE Recall D-0971-2022

Description: 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

HYDROCHLOROTHIAZIDE Recall D-0971-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0971-2022
Event ID90161
BrandLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Generic NameLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ManufacturerLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Active SubstanceHYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM
Drug RouteORAL
DistributionAL, GA, FL, LA
Quantity81 bottles
Recall ReasonCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Drug ClassificationClass II
Drug Code Info20220608
Product NDC72189-012 72189-098 72189-129
Product NUIN0000175359 N0000175419 M0471776
Pharma Class (PE)Increased Diuresis [PE]
Pharma Class (EPC)Thiazide Diuretic [EPC]
Pharma Class (CS)Thiazides [CS]
Recall Initiation Date20220505
Report Date20220608
Classification Date20220527
Address94 Worldwide Dr
Dawsonville, GA 30534-6828
United States
Recalling FirmDirect Rx
Initial Notification Letter
Unique Ingredient Identifier0J48LPH2TH 3ST302B24A
Drug Application NumberANDA091629
Structured Product Labeling (SPL ID)cf41f400-4188-72ca-e053-2995a90a6142
Structured Product Labeling (SPL Set ID)8de04bf2-83dd-c494-e053-2a95a90abade
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