Why it was recalled
Failed Impurity/Degradation Specifications
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
Lot numbers, UPCs & expiration codes
Lot #: C00113, Exp. Date 11/2024; C00125, Exp. Date 04/2025; C00145, Exp. Date 07/2025
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0050-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 7, 2024
- FDA report date
- Nov 27, 2024
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Original FDA data
Every field from FDA enforcement report D-0050-2025, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 95705
- Address
- 341 Mason Rd
- Code information
- Lot #: C00113, Exp. Date 11/2024; C00125, Exp. Date 04/2025; C00145, Exp. Date 07/2025
- Postal code
- 37086-3606
- Report date
- Nov 27, 2024
- Product type
- Drugs
- Recall number
- D-0050-2025
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Termination date
- Mar 5, 2026
- Reason for recall
- Failed Impurity/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 7, 2024
- Initial firm notification
- Letter
- Center classification date
- Nov 18, 2024