Seaway Pharma Inc.: Drug Recall
Recall #D-0215-2024 · 12/28/2023
Class II: Risk
Recall Details
- Recall Number
- D-0215-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Seaway Pharma Inc.
- Status
- Ongoing
- Date Initiated
- 12/28/2023
- Location
- Massena, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- 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.
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
Other Recalls by Seaway Pharma Inc.
- Class II: Risk 12/28/2023
- Class II: Risk 12/28/2023
- Class II: Risk 12/28/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.