OCEAN Saline Nasal Spray recalled over manufacturing violations

Recall date

August 3, 2018

Source

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

Official notice title

Product Quest Manufacturing LLC recalls OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz.) UPC 3…

Recall number

D-0055-2019

FDA classification

Class II

Brand / firm

Product Quest Manufacturing LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

CGMP Deviations: products manufactured under conditions that could impact its product quality.

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

What was recalled

OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz.) UPC 3 01875 26003 3, c) Buddy Pack containing one 1.5 FL. OZ. (44 mL) and one 0.76 FL.OZ. (22 mL) bottle per carton, Distributed by: Valeant Consumer Products, A Division of Valeant Pharmaceuticals, North America LLC, Bridgewater, NJ 08807.