The Recall Desk

FDA (Drugs) recall action 95705

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled 2 products on 2024-11-27

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-11-27
Critical
0
Units
—

Why these products were recalled

Failed Impurity/Degradation Specifications

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • HighFDA (Drugs)··2024-11-27

    Guaifenesin Dextromethorphan Syrup Recalled for Failed Quality Specifications

    Major Pharmaceuticals has recalled Guaifenesin Dextromethorphan Syrup due to failed impurity and degradation specifications. Three lot numbers were distributed nationwide.

    Product
    Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-11-27

    Guaifenesin-Dextromethorphan Cough Syrup Recalled for Failed Impurity Specifications

    Major Pharmaceuticals is recalling Guaifenesin Dextromethorphan Syrup nationwide for specific lots that failed to meet impurity and degradation specifications. Consumers should contact their pharmacist if they possess affected lots.

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