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HYDROCHLOROTHIAZIDE Recall D-0836-2022

Description: Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

HYDROCHLOROTHIAZIDE Recall D-0836-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0836-2022
Event ID90037
BrandLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Generic NameLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ManufacturerLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Original Package?1
Active SubstanceHYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM
Drug RouteORAL
DistributionProduct was distributed nationwide.
Recall ReasonCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Drug ClassificationClass II
Drug Code Info20220511
Product NDC33342-050 33342-051 33342-052
Product NUIN0000175359 N0000175419 M0471776
Drug UPC0333342051448 0333342051103 0333342051073
Pharma Class (PE)Increased Diuresis [PE]
Pharma Class (EPC)Thiazide Diuretic [EPC]
Pharma Class (CS)Thiazides [CS]
Recall Initiation Date20220415
Report Date20220511
Classification Date20220503
Address666 Plainsboro Rd Bldg 200 Ste 230
Plainsboro, NJ 08536-0009
United States
Recalling FirmMacleods Pharma Usa Inc
Initial Notification Letter
Unique Ingredient Identifier0J48LPH2TH 3ST302B24A
Drug Application NumberANDA202289
Structured Product Labeling (SPL ID)d5579695-0912-403b-9a85-33522bc98112
Structured Product Labeling (SPL Set ID)a04b5622-2c49-4d61-92b1-5dc523af7a24
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