PlainRecalls
FDA Drug Moderate Class II Terminated

Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440

Reported: August 24, 2022 Initiated: July 15, 2022 #D-1357-2022

Product Description

Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440

Reason for Recall

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

Details

Units Affected
4,632 cartons
Distribution
Florida, Illinois, Iowa, New Jersey
Location
Nixa, MO

Frequently Asked Questions

What product was recalled?
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440. Recalled by Aire-Master of America Inc. Units affected: 4,632 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-1357-2022.