FDA-Drug2024-11-27Class II

Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Hazard

Failed Impurity/Degradation Specifications

Sold states
Nationwide within the United States
Affected count
N/A
Manufactured in
341 Mason Rd, N/A, La Vergne, TN, United States
Products
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0050-2025

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