PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: October 24, 2018 Initiated: August 3, 2018 #D-0050-2019

Product Description

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.

Reason for Recall

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

Details

Units Affected
172,800 bottles
Distribution
Nationwide in the USA
Location
Daytona Beach, FL

Frequently Asked Questions

What product 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.. Recalled by Product Quest Manufacturing LLC. Units affected: 172,800 bottles.
Why was this product recalled?
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 24, 2018. Severity: Moderate. Recall number: D-0050-2019.