FDAHealthNovember 7, 2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapoli
⚠️ Failed Impurity/Degradation Specifications
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 7, 2024
Nationwide within the United States
What's affected?
- Product
- Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
- Lot code
- C00113
Additional details
Lot #: C00113, Exp. Date 11/2024; C00125, Exp. Date 04/2025; C00145, Exp. Date 07/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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