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HYDROCHLOROTHIAZIDE Recall D-1305-2022

Description: Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430, NDC 68462-842-13.

HYDROCHLOROTHIAZIDE Recall D-1305-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1305-2022
Event ID90541
BrandTELMISARTAN AND HYDROCHLOROTHIAZIDE
Generic NameTELMISARTAN AND HYDROCHLOROTHIAZIDE
ManufacturerTELMISARTAN AND HYDROCHLOROTHIAZIDE
Original Package?1
Active SubstanceHYDROCHLOROTHIAZIDE TELMISARTAN
Drug RouteORAL
Distributionnationwide
Quantity72288 units
Recall ReasonPackaging : Blister package issues.
Drug ClassificationClass II
Drug Code Info20220817
Product NDC68462-840 68462-841 68462-842
Product NUIN0000000070 N0000175561 N0000175359
Pharma Class (PE)Increased Diuresis [PE]
Pharma Class (EPC)Angiotensin 2 Receptor Blocker [EPC]
Pharma Class (CS)Thiazides [CS]
Recall Initiation Date20220629
Report Date20220817
Classification Date20220805
Address750 Corporate Dr
Mahwah, NJ 07430-2009
United States
Recalling FirmGlenmark Pharmaceuticals Inc., USA
Initial Notification Letter
Unique Ingredient IdentifierU5SYW473RQ 0J48LPH2TH
Drug Application NumberANDA202544
Structured Product Labeling (SPL ID)2dffa49a-ea8c-455f-9776-7a91ca723884
Structured Product Labeling (SPL Set ID)1e55800d-f77c-4950-a6d7-2055f4c7ea17
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