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BISOPROLOL FUMARATE Recall D-0085-2024

Description: Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01

BISOPROLOL FUMARATE Recall D-0085-2024 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0085-2024
Event ID93252
BrandBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Generic NameBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
ManufacturerBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Original Package?1
Active SubstanceBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE
Drug RouteORAL
DistributionNationwide in the USA
Quantity480 100-count bottles
Recall ReasonFailed Impurities/Degradation Specifications
Drug ClassificationClass III
Drug Code Info20231108
Product NDC68462-878 68462-879 68462-880
Product NUIN0000175359 N0000175419 M0471776
Drug UPC0368462879306 0368462878309 0368462880302
Pharma Class (PE)Increased Diuresis [PE]
Pharma Class (EPC)Thiazide Diuretic [EPC]
Pharma Class (CS)Thiazides [CS]
Recall Initiation Date20231020
Report Date20231108
Classification Date20231102
Address750 Corporate Dr
Mahwah, NJ 07430-2009
United States
Recalling FirmGlenmark Pharmaceuticals Inc., USA
Initial Notification Letter
Unique Ingredient Identifier0J48LPH2TH UR59KN573L
Drug Application NumberANDA215995
Structured Product Labeling (SPL ID)4cf012b1-384c-4112-bc27-70d6c6d1d124
Structured Product Labeling (SPL Set ID)ab73a6d8-2e33-4fdc-a896-6c68ab772da6
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