FDAFDA · Food and drugs·Recall number D-0215-2024
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.
Published January 10, 2024 · Recall initiated: December 28, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Seaway Pharma Inc.
- Distributor
- MI, PA
- Lot
- Lot # SD23033, Exp 04/30/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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