PlainRecalls
FDA Drug Moderate Class II Terminated

Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bottle, Sinus Reliever, Nasal Decongestant, 12 Hour Pump Mist, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7000-01, UPC 3 11917 18535 4.

Reported: October 24, 2018 Initiated: August 3, 2018 #D-0062-2019

Product Description

Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bottle, Sinus Reliever, Nasal Decongestant, 12 Hour Pump Mist, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7000-01, UPC 3 11917 18535 4.

Reason for Recall

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

Details

Units Affected
361,104 bottles
Distribution
Nationwide in the USA
Location
Daytona Beach, FL

Frequently Asked Questions

What product was recalled?
Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bottle, Sinus Reliever, Nasal Decongestant, 12 Hour Pump Mist, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7000-01, UPC 3 11917 18535 4.. Recalled by Product Quest Manufacturing LLC. Units affected: 361,104 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-0062-2019.