QC Quality Choice 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 QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%, packaged as a) 1.5 FL OZ (45 m…

Recall number

D-0050-2019

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

QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%, packaged as a) 1.5 FL OZ (45 mL) bottle UPC 6 35515 98845 3; b) 3 FL OZ (89 mL) bottle UPC 6 35515 95042 9, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995.