MONTELUKAST SODIUM Recall D-0400-2023
Description: Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b) 90-count bottle NDC 16729-119-15 UPC 3 16729 11915 3; c) 1,000-count bottle NDC 16729-119-17 UPC 3 16729 11917 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
MONTELUKAST SODIUM Recall D-0400-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0400-2023 |
| Event ID | 91657 |
| Brand | MONTELUKAST SODIUM |
| Generic Name | MONTELUKAST SODIUM |
| Manufacturer | MONTELUKAST SODIUM |
| Original Package? | 1 |
| Active Substance | MONTELUKAST SODIUM |
| Drug Route | ORAL |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 665,469 bottles |
| Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 16729-119 |
| Drug UPC | 0316729119108 316729119108 316729119153 |
| Recall Initiation Date | 20230207 |
| Report Date | 20230308 |
| Classification Date | 20230302 |
| Address | 1009 Slater Rd Ste 210B Durham, NC 27703-8446 United States |
| Recalling Firm | Accord Healthcare, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | U1O3J18SFL |
| Drug Application Number | ANDA202717 |
| Structured Product Labeling (SPL ID) | d481e75b-ffed-a218-e053-2995a90a19c5 |
| Structured Product Labeling (SPL Set ID) | 6eea668f-a2fa-447f-b2d5-4c754d13d9fa |
| Similar To |