Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
Recall Number: D-0050-2025
Firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Classification: Class II
Status: Terminated
Report Date: 20241127
Initiation Date: 20241107
Termination Date: 20260305
Reason for Recall
Failed Impurity/Degradation Specifications
Product Description
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70