Product Safety Recalls

Product Recall Tracker

LOSARTAN POTASSIUM Recall D-0834-2022

Description: Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

LOSARTAN POTASSIUM Recall D-0834-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0834-2022
Event ID90037
BrandLOSARTAN POTASSIUM
Generic NameLOSARTAN POTASSIUM
ManufacturerLOSARTAN POTASSIUM
Original Package?1
Active SubstanceLOSARTAN POTASSIUM
Drug RouteORAL
DistributionProduct was distributed nationwide.
Quantity3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets
Recall ReasonCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Drug ClassificationClass II
Drug Code Info20220511
Product NDC33342-044 33342-045 33342-046
Drug UPC0333342045102 0333342046109 0333342045072
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 Identifier3ST302B24A
Drug Application NumberANDA202230
Structured Product Labeling (SPL ID)ed9b01e6-3ada-45f7-86ac-6361f9956326
Structured Product Labeling (SPL Set ID)85d69d02-c5ef-467e-94aa-903100218795
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