PlainRecalls
FDA Drug Moderate 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.

Reported: January 10, 2024 Initiated: December 28, 2023 #D-0215-2024

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.

Details

Recalling Firm
Seaway Pharma Inc.
Units Affected
4,176 bottles
Distribution
MI, PA
Location
Massena, NY

Frequently Asked Questions

What product 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.. Recalled by Seaway Pharma Inc.. Units affected: 4,176 bottles.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 10, 2024. Severity: Moderate. Recall number: D-0215-2024.