Why it was recalled
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Product description
Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4.
Lot numbers, UPCs & expiration codes
Lot # SD23033, Exp 04/30/2025
Where it was sold
MI, PA
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-0215-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 28, 2023
- FDA report date
- Jan 10, 2024
- Quantity
- 4,176 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Seaway Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0215-2024, exactly as published.
Show all FDA fields
- City
- Massena
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 93708
- Address
- 5 County Route 42
- Code information
- Lot # SD23033, Exp 04/30/2025
- Postal code
- 13662-1569
- Report date
- Jan 10, 2024
- Product type
- Drugs
- Recall number
- D-0215-2024
- Classification
- Class II
- Recalling firm
- Seaway Pharma Inc.
- Product quantity
- 4,176 bottles
- Reason for recall
- CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4.
- Distribution pattern
- MI, PA
- Recall initiation date
- Dec 28, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 4, 2024