Premier Value 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, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodium Chloride) Solution, 4.25 FL OZ (126 mL)…

Recall number

D-0046-2019

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, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodium Chloride) Solution, 4.25 FL OZ (126 mL) can, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 8 40986 02998 1.