PlainRecalls
FDA Drug Moderate Class II Terminated

Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.

Reported: August 24, 2022 Initiated: July 15, 2022 #D-1358-2022

Product Description

Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.

Reason for Recall

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

Details

Units Affected
960 cartons
Distribution
Florida, Illinois, Iowa, New Jersey
Location
Nixa, MO

Frequently Asked Questions

What product was recalled?
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.. Recalled by Aire-Master of America Inc. Units affected: 960 cartons.
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-1358-2022.