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

FDA recall notice · announced November 27, 2024 · The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: C00113, Exp. Date 11/2024; C00125, Exp. Date 04/2025; C00145, Exp. Date 07/2025
Quantity: N/A
Status: Terminated
Products in this recall event:
- Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72 (D-0049-2025)
- Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70 (D-0050-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.