# FDA recall D-0215-2024

> **Seaway Pharma Inc.** · Class II · drug recall initiated 2023-12-28.

## 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.

## 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

MI, PA

## Key facts

- **Recall number:** D-0215-2024
- **Recalling firm:** Seaway Pharma Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-12-28
- **Report date:** 2024-01-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Massena, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0215-2024

## Citation

> AI Analytics. FDA recall D-0215-2024. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/D-0215-2024. Source: US FDA. Licensed CC0.

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