Recall D-0049-2025

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, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72

Reason for recall

Failed Impurity/Degradation Specifications

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