DEXTROMETHORPHAN HYDROBROMIDE Recall D-0787-2022
Description: Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0324-28.
DEXTROMETHORPHAN HYDROBROMIDE Recall D-0787-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0787-2022 |
| Event ID | 89905 |
| Brand | WAL-TUSSIN DM |
| Generic Name | DEXTROMETHORPHAN HBR, GUAIFENESIN |
| Manufacturer | DEXTROMETHORPHAN HBR, GUAIFENESIN |
| Original Package? | 1 |
| Active Substance | DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN |
| Drug Route | ORAL |
| Distribution | IL only |
| Quantity | 117,552 units |
| Recall Reason | Incorrect/Undeclared Excipient: Product contains alcohol |
| Drug Classification | Class III |
| Drug Code Info | 20220504 |
| Product NDC | 0363-0324 |
| Product NUI | N0000193956 N0000008867 N0000009560 |
| Pharma Class (PE) | Decreased Respiratory Secretion Viscosity [PE] |
| Pharma Class (EPC) | Expectorant [EPC] |
| Recall Initiation Date | 20220329 |
| Report Date | 20220504 |
| Classification Date | 20220425 |
| Address | 1533 Union Ave Pennsauken, NJ 08110-2489 United States |
| Recalling Firm | AptaPharma Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 9D2RTI9KYH 495W7451VQ |
| Drug Application Number | part341 |
| Structured Product Labeling (SPL ID) | ae894d3e-edb5-4a67-bedd-76f9f7905be0 |
| Structured Product Labeling (SPL Set ID) | 054b44e8-0226-4cbd-a113-13da0ac90f05 |
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