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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1305-2022 |
| Event ID | 90541 |
| Brand | TELMISARTAN AND HYDROCHLOROTHIAZIDE |
| Generic Name | TELMISARTAN AND HYDROCHLOROTHIAZIDE |
| Manufacturer | TELMISARTAN AND HYDROCHLOROTHIAZIDE |
| Original Package? | 1 |
| Active Substance | HYDROCHLOROTHIAZIDE TELMISARTAN |
| Drug Route | ORAL |
| Distribution | nationwide |
| Quantity | 72288 units |
| Recall Reason | Packaging : Blister package issues. |
| Drug Classification | Class II |
| Drug Code Info | 20220817 |
| Product NDC | 68462-840 68462-841 68462-842 |
| Product NUI | N0000000070 N0000175561 N0000175359 |
| Pharma Class (PE) | Increased Diuresis [PE] |
| Pharma Class (EPC) | Angiotensin 2 Receptor Blocker [EPC] |
| Pharma Class (CS) | Thiazides [CS] |
| Recall Initiation Date | 20220629 |
| Report Date | 20220817 |
| Classification Date | 20220805 |
| Address | 750 Corporate Dr Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | U5SYW473RQ 0J48LPH2TH |
| Drug Application Number | ANDA202544 |
| 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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