Seaway Pharma product recalled over manufacturing violations

Recall date

December 28, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Seaway Pharma Inc. recalls Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant…

Recall number

D-0216-2024

FDA classification

Class II

Brand / firm

Seaway Pharma Inc.

Sold / distributed

MI, PA

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7.