PlainRecalls
FDA Drug Moderate Class II Terminated

TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village, IL 60007, UPC 0 36800 42146 2.

Reported: October 24, 2018 Initiated: August 3, 2018 #D-0054-2019

Product Description

TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village, IL 60007, UPC 0 36800 42146 2.

Reason for Recall

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

Details

Units Affected
7,488 tubes
Distribution
Nationwide in the USA
Location
Daytona Beach, FL

Frequently Asked Questions

What product was recalled?
TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village, IL 60007, UPC 0 36800 42146 2.. Recalled by Product Quest Manufacturing LLC. Units affected: 7,488 tubes.
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-0054-2019.