Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle Supply Disruption — Accord Healthcare, Inc. (Mode
Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle Supply Disruption — Accord Healthcare, Inc. (Mode is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle; Manufacturer: Accor
| Drug name | Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle |
|---|---|
| Manufacturer | Accord Healthcare, Inc. |
| Recall/Disruption reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-0400-2023 |
| Initiation date | 20230207 |
| Quantity affected | 665,469 bottles |
| Dosage form | Drugs |
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