FDA Recall D-0215-2024

Seaway Pharma Inc. · Massena, NY

Class II Ongoing 868 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot # SD23033, Exp 04/30/2025

Quantity: 4,176 bottles

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.

Recall record

Recall number: D-0215-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: MI, PA
Recall initiated: 2023-12-28
Classified by FDA Center: 2024-01-04
FDA published: 2024-01-10
Recalling firm: Seaway Pharma Inc.
Firm location: Massena, NY

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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