FDAClass IIAugust 24, 2022

Protect U Guard Foaming Hand Sanitizer Ophardt recall: CGMP Deviations

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

Why was Protect U Guard Foaming Hand Sanitizer Ophardt recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Number 46112, Lots 722782 -exp 08/22

Product
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
Recalling firm
Aire-Master of America Inc
Quantity
960 cartons
Distribution
Florida, Illinois, Iowa, New Jersey
Recall date
August 24, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls