PlainRecalls
FDA Drug Moderate Class II Terminated

HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02742 68045 9 .

Reported: October 24, 2018 Initiated: August 3, 2018 #D-0043-2019

Product Description

HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02742 68045 9 .

Reason for Recall

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

Details

Units Affected
3264 bottles
Distribution
Nationwide in the USA
Location
Daytona Beach, FL

Frequently Asked Questions

What product was recalled?
HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02742 68045 9 .. Recalled by Product Quest Manufacturing LLC. Units affected: 3264 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-0043-2019.