MONTELUKAST SODIUM Recall D-0518-2023
Description: Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
MONTELUKAST SODIUM Recall D-0518-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0518-2023 |
| Event ID | 91952 |
| Brand | MONTELUKAST SODIUM |
| Generic Name | MONTELUKAST SODIUM |
| Manufacturer | MONTELUKAST SODIUM |
| Active Substance | MONTELUKAST SODIUM |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Quantity | a) 266 Bottles, b) not reported, c) 216 Bottles |
| Recall Reason | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230412 |
| Product NDC | 68788-9438 |
| Recall Initiation Date | 20230323 |
| Report Date | 20230412 |
| Classification Date | 20230406 |
| Address | 1250 N Lakeview Ave Ste O Anaheim, CA 92807-1801 United States |
| Recalling Firm | Preferred Pharmaceuticals, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | U1O3J18SFL |
| Drug Application Number | ANDA202717 |
| Structured Product Labeling (SPL ID) | 83e555c5-e380-4f2d-95ef-d406a902eed1 |
| Structured Product Labeling (SPL Set ID) | 8ae3f1fc-4bc1-4412-96d0-deb7eed74c08 |
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