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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0085-2024 |
| Event ID | 93252 |
| Brand | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
| Generic Name | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
| Manufacturer | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
| Original Package? | 1 |
| Active Substance | BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 480 100-count bottles |
| Recall Reason | Failed Impurities/Degradation Specifications |
| Drug Classification | Class III |
| Drug Code Info | 20231108 |
| Product NDC | 68462-878 68462-879 68462-880 |
| Product NUI | N0000175359 N0000175419 M0471776 |
| Drug UPC | 0368462879306 0368462878309 0368462880302 |
| Pharma Class (PE) | Increased Diuresis [PE] |
| Pharma Class (EPC) | Thiazide Diuretic [EPC] |
| Pharma Class (CS) | Thiazides [CS] |
| Recall Initiation Date | 20231020 |
| Report Date | 20231108 |
| Classification Date | 20231102 |
| Address | 750 Corporate Dr Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 0J48LPH2TH UR59KN573L |
| Drug Application Number | ANDA215995 |
| 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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