Premier Value Nasal Decongestant Extra Moisturizing 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 Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottle, Dist…

Recall number

D-0044-2019

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

Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-304-03, UPC 8 40986 01518 2.