🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: November 7, 2024 The Harvard Drug Group LLC Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: C00113, Exp. Date 11/2024; C00125, Exp. Date 04/2025; C00145, Exp. Date 07/2025
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Reason for Recall:
Failed Impurity/Degradation Specifications
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
completed

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot #: C00113, Exp. Date 11/2024; C00125, Exp. Date 04/2025; C00145, Exp. Date 07/2025

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0050-2025

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