RIZATRIPTAN BENZOATE Recall D-0535-2024
Description: Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06
RIZATRIPTAN BENZOATE Recall D-0535-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0535-2024 |
| Event ID | 94608 |
| Brand | RIZATRIPTAN BENZOATE |
| Generic Name | RIZATRIPTAN BENZOATE |
| Manufacturer | RIZATRIPTAN BENZOATE |
| Original Package? | 1 |
| Active Substance | RIZATRIPTAN BENZOATE |
| Drug Route | ORAL |
| Distribution | US Nationwide. |
| Quantity | 25,904 cartons |
| Recall Reason | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. |
| Drug Classification | Class II |
| Drug Code Info | 20240612 |
| Product NDC | 68462-467 68462-468 |
| Drug UPC | 0368462467060 0368462468067 |
| Recall Initiation Date | 20240513 |
| Report Date | 20240612 |
| Classification Date | 20240604 |
| Address | 750 Corporate DrN/A Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | WR978S7QHH |
| Drug Application Number | ANDA201914 |
| Structured Product Labeling (SPL ID) | d0d83e24-265b-4802-96e0-e0d18bef299d |
| Structured Product Labeling (SPL Set ID) | 4de33a24-db69-444a-b04d-c69ccba57ab2 |
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