MONTELUKAST SODIUM Recall D-0510-2023
Description: Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
MONTELUKAST SODIUM Recall D-0510-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0510-2023 |
| Event ID | 91958 |
| Brand | MONTELUKAST SODIUM |
| Generic Name | MONTELUKAST SODIUM |
| Manufacturer | MONTELUKAST SODIUM |
| Original Package? | 1 |
| Active Substance | MONTELUKAST SODIUM |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Quantity | 3,772 cartons |
| Recall Reason | Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A. |
| Drug Classification | Class III |
| Drug Code Info | 20230412 |
| Product NDC | 0093-7487 |
| Recall Initiation Date | 20230327 |
| Report Date | 20230412 |
| Classification Date | 20230406 |
| Address | 400 Interpace Pkwy Bldg A Parsippany, NJ 07054-1120 United States |
| Recalling Firm | Teva Pharmaceuticals USA Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | U1O3J18SFL |
| Drug Application Number | ANDA090955 |
| Structured Product Labeling (SPL ID) | e439ab83-caf7-4853-981d-e648277733b3 |
| Structured Product Labeling (SPL Set ID) | ad5a77e1-cd4c-48da-8b65-f3e97433e5df |
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