D-0215-2024 Class II Ongoing

Recalled by Seaway Pharma Inc. — Massena, NY

Recall Details

Product Type
Drugs
Report Date
January 10, 2024
Initiation Date
December 28, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,176 bottles

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.

Distribution Pattern

MI, PA

Code Information

Lot # SD23033, Exp 04/30/2025