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HYDROCHLOROTHIAZIDE Recall D-0841-2022

Description: Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.

HYDROCHLOROTHIAZIDE Recall D-0841-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0841-2022
Event ID89916
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
Quantity1,214,016 bottles
Recall ReasonCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Drug ClassificationClass II
Drug Code Info20220511
Product NDC68180-215 68180-216 68180-217
Product NUIN0000175359 N0000175419 M0471776
Drug UPC0006018000070 0368180216063 0368180215066
Pharma Class (PE)Increased Diuresis [PE]
Pharma Class (EPC)Thiazide Diuretic [EPC]
Pharma Class (CS)Thiazides [CS]
Recall Initiation Date20220331
Report Date20220511
Classification Date20220503
AddressHarborplace Tower111 S Calvert St Fl 21st
Baltimore, MD 21202-6174
United States
Recalling FirmLupin Pharmaceuticals Inc.
Initial Notification Letter
Unique Ingredient Identifier0J48LPH2TH 3ST302B24A
Drug Application NumberANDA078245
Structured Product Labeling (SPL ID)d6b52688-486b-4256-b9f7-667ec6163dd3
Structured Product Labeling (SPL Set ID)ee1eaaf6-050b-48af-942b-5e3451edc164
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