Status
Completed
Drug Enforcement D-0050-2025
Failed Impurity/Degradation Specifications
Classification
Class II
Report Date
November 27, 2024
Termination Date
—
Product Information
- Product description
- Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
- Product quantity
- N/A
- Reason for recall
- Failed Impurity/Degradation Specifications
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Address
-
341 Mason Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0050-2025
- Event ID
- 95705
- Recall initiation date
- November 7, 2024
- Center classification date
- November 18, 2024
- Code info
- Lot #: C00113, Exp. Date 11/2024; C00125, Exp. Date 04/2025; C00145, Exp. Date 07/2025
- More code info
- —