Recalls / Class II

Class IID-0215-2024

Product

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.

Affected lot / code info

Lot # SD23033, Exp 04/30/2025

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.

Recalling firm

Firm

Seaway Pharma Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

5 County Route 42, N/A, Massena, New York 13662-1569

Distribution

Quantity

4,176 bottles

Distribution pattern

MI, PA

Timeline

Recall initiated

2023-12-28

FDA classified

2024-01-04

Posted by FDA

2024-01-10

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0215-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.