Premier Value Tussin Cough DM recalled over manufacturing violations

Recall date

December 28, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Seaway Pharma Inc. recalls Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL…

Recall number

D-0215-2024

FDA classification

Class II

Brand / firm

Seaway Pharma Inc.

Sold / distributed

MI, PA

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.