FDA recall D-0049-2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Class II · drug
Product
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72
Reason for recall
Failed Impurity/Degradation Specifications
Distribution
Nationwide within the United States
Key facts
- Status
- Terminated
- Initiation date
- 2024-11-07
- Report date
- 2024-11-27
- Termination date
- 2026-03-05
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- La Vergne, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0049-2025