DEXTROMETHORPHAN HYDROBROMIDE Recall D-0050-2025
Description: Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
DEXTROMETHORPHAN HYDROBROMIDE Recall D-0050-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0050-2025 |
| Event ID | 95705 |
| Brand | CHEST CONGESTION RELIEF |
| Generic Name | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN |
| Manufacturer | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN |
| Active Substance | DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN |
| Drug Route | ORAL |
| Distribution | Nationwide within the United States |
| Quantity | N/A |
| Recall Reason | Failed Impurity/Degradation Specifications |
| Drug Classification | Class II |
| Drug Code Info | 20241127 |
| Product NDC | 0904-7134 |
| Product NUI | N0000193956 N0000008867 N0000009560 |
| Drug UPC | 0309047134700 |
| Pharma Class (PE) | Decreased Respiratory Secretion Viscosity [PE] |
| Pharma Class (EPC) | Expectorant [EPC] |
| Recall Initiation Date | 20241107 |
| Report Date | 20241127 |
| Classification Date | 20241118 |
| Address | 341 Mason RdN/A La Vergne, TN 37086-3606 United States |
| Recalling Firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 9D2RTI9KYH 495W7451VQ |
| Drug Application Number | M012 |
| Structured Product Labeling (SPL ID) | b436ac4b-91da-43d4-9695-b65b7ec0d5e4 |
| Structured Product Labeling (SPL Set ID) | 527b944a-b59e-4e83-86d7-69b852e892db |
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