Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Dri...
FDA Recall #D-0049-2025 — Class II — November 7, 2024
Product Description
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
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — La Vergne, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Nationwide within the United States
Code Information
Lot #: C00128, Exp. Date 04/2025; C00146, Exp.Date 07/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated