Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Quality Choice No Drip Severe Congestion Nasal Pump Mist Recalled by Seaway Pharma Inc. Due to CGMP Deviations: Firm reported possible microbial contamination in...

Date: December 28, 2023
Company: Seaway Pharma Inc.
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Seaway Pharma Inc. directly.

Affected Products

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

Quantity: 8,160 bottles

Why Was This 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.

Where Was This Sold?

This product was distributed to 2 states: MI, PA

Affected (2 states)Not affected

About Seaway Pharma Inc.

Seaway Pharma Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report