Drug recall
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100…
FDA recall event 95705 · Class II · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Key facts
| Event ID | 95705 |
|---|---|
| Recall numbers | D-0049-2025, D-0050-2025 |
| Recalling firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories |
| Product type | Drugs |
| Products | Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70, Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72 |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurity/Degradation Specifications |
| Initiation date | Nov 7, 2024 |
| Report date | Nov 27, 2024 |
| City | La Vergne |
| State | TN |
| Country | United States |
| FEI number | 1818658 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: