Recall D-0050-2025

US Class II Terminated · initiated 2024-11-07

Recalling firm

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, TN

Product

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

Reason for recall

Failed Impurity/Degradation Specifications

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