PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: October 24, 2018 Initiated: August 3, 2018 #D-0044-2019

Product Description

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.

Reason for Recall

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

Details

Units Affected
8592 bottles
Distribution
Nationwide in the USA
Location
Daytona Beach, FL

Frequently Asked Questions

What product 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.. Recalled by Product Quest Manufacturing LLC. Units affected: 8592 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-0044-2019.