Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Do Supply Disruption — Glenmark Pharmaceuticals Inc.
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Do Supply Disruption — Glenmark Pharmaceuticals Inc. is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Do; Manufacturer: Glenm
| Drug name | Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Do |
|---|---|
| Manufacturer | Glenmark Pharmaceuticals Inc., USA |
| Recall/Disruption reason | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Ongoing |
| Record type | Enforcement/Recall |
| Recall number | D-0535-2024 |
| Initiation date | 20240513 |
| Quantity affected | 13296 cartons |
| Dosage form | Drugs |
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