The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianap…
- Recall date
- November 7, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0050-2025
- FDA classification
- Class II
- Brand / firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Failed Impurity/Degradation Specifications
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
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