PlainRecalls
FDA Drug Moderate Class II Completed

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

Reported: November 27, 2024 Initiated: November 7, 2024 #D-0049-2025

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

Details

Units Affected
N/A
Distribution
Nationwide within the United States
Location
La Vergne, TN

Frequently Asked Questions

What product was recalled?
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72. Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Units affected: N/A.
Why was this product recalled?
Failed Impurity/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on November 27, 2024. Severity: Moderate. Recall number: D-0049-2025.