Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
Reported: November 27, 2024 Initiated: November 7, 2024 #D-0050-2025
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
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, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70. 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-0050-2025.
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