# FDA recall D-0217-2024

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

## Product

Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0

## 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-0217-2024
- **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-0217-2024

## Citation

> AI Analytics. FDA recall D-0217-2024. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-0217-2024. Source: US FDA. Licensed CC0.

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