Home / Recalls / Aire-Master of America Inc / D-1358-2022

D-1358-2022 Class II Terminated

Recalled by Aire-Master of America Inc — Nixa, MO

Recall Details

Product Type
Drugs
Report Date
August 24, 2022
Initiation Date
July 15, 2022
Termination Date
February 19, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
960 cartons

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.

Distribution Pattern

Florida, Illinois, Iowa, New Jersey

Code Information

Product Number 46112, Lots 722782 -exp 08/22

Other recalls by Aire-Master of America Inc

  • D-1357-2022 Class II — Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) p (July 15, 2022)
  • D-1356-2022 Class II — Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per (July 15, 2022)
  • D-1359-2022 Class II — Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per b (July 15, 2022)
  • D-1360-2022 Class II — Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, (July 15, 2022)
  • D-1355-2022 Class II — Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 100 (July 15, 2022)