Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectoran...
FDA Recall #D-0215-2024 — Class II — December 28, 2023
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.
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.
Recalling Firm
Seaway Pharma Inc. — Massena, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4,176 bottles
Distribution
MI, PA
Code Information
Lot # SD23033, Exp 04/30/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated