Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution 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 Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality C…

Recall number

D-0214-2024

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

Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-35515-98843-9, b) Premier Value, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne, PA 19087 UPC 8-40986-03509-8.