Product Safety Recalls

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HYDROCHLOROTHIAZIDE Recall D-0895-2022

Description: Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

HYDROCHLOROTHIAZIDE Recall D-0895-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0895-2022
Event ID90200
BrandLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Generic NameLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ManufacturerLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Active SubstanceHYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM
Drug RouteORAL
DistributionFL
Quantity11 bottles
Recall ReasonCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Drug ClassificationClass II
Drug Code Info20220601
Product NDC72189-289
Product NUIN0000175359 N0000175419 M0471776
Pharma Class (PE)Increased Diuresis [PE]
Pharma Class (EPC)Thiazide Diuretic [EPC]
Pharma Class (CS)Thiazides [CS]
Recall Initiation Date20220511
Report Date20220601
Classification Date20220524
Address94 Worldwide Dr
Dawsonville, GA 30534-6828
United States
Recalling FirmDirect Rx
Initial Notification Letter
Unique Ingredient Identifier0J48LPH2TH 3ST302B24A
Drug Application NumberANDA202289
Structured Product Labeling (SPL ID)d1ed9593-a588-55bb-e053-2995a90a8a9a
Structured Product Labeling (SPL Set ID)d1ed9593-a587-55bb-e053-2995a90a8a9a
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