Class II
Ongoing
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.
This recall is currently active, issued January 10, 2024. It was issued by Seaway Pharma Inc..
- Company
- Seaway Pharma Inc.
- Recall Initiated
- December 28, 2023
- Posted
- January 10, 2024
- Recall Number
- D-0215-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,176 bottles
- Firm Location
- Massena, NY, United States
- Official Source
- View on FDA website ↗
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.
Distribution
MI, PA
Lot / Code Info
Lot # SD23033, Exp 04/30/2025
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