Aire-Master of America Inc: Drug Recall

Recall #D-1359-2022 · 07/15/2022

Class II: Risk

Recall Details

Recall Number
D-1359-2022
Classification
Class II
Product Type
Drug
Recalling Firm
Aire-Master of America Inc
Status
Terminated
Date Initiated
07/15/2022
Location
Nixa, MO, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,064 bottles

Reason for Recall

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

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

Distribution Pattern

Florida, Illinois, Iowa, New Jersey

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.