PlainRecalls
FDA Drug Moderate Class II Terminated

Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606

Reported: August 24, 2022 Initiated: July 15, 2022 #D-1359-2022

Product Description

Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606

Reason for Recall

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Details

Units Affected
5,064 bottles
Distribution
Florida, Illinois, Iowa, New Jersey
Location
Nixa, MO

Frequently Asked Questions

What product was recalled?
Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606. Recalled by Aire-Master of America Inc. Units affected: 5,064 bottles.
Why was this product recalled?
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 24, 2022. Severity: Moderate. Recall number: D-1359-2022.