The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1358-2022·Announced 2022-08-24

Hand Sanitizer Recalled for Manufacturing Process Deficiency

Protect U Guard Foaming Hand Sanitizer is being recalled due to a manufacturing deficiency in the deionized water system. The product was distributed in Florida, Illinois, Iowa, and New Jersey.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a theoretical microbial contamination hazard with no reported illnesses or injuries. The precautionary nature of the recall and absence of confirmed harm classify this as Moderate severity.

Plain-English summary

Aire-Master of America Inc is recalling Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free (1000 mL cartons). The recall was initiated due to a manufacturing deficiency: the product was made using deionized water from a system that did not have adequate microbial control after deionization.

The recalled product, identified by Product Number 46112 and Lots 722782 (expiration 08/22), was distributed in Florida, Illinois, Iowa, and New Jersey. Approximately 960 cartons are affected.

Consumers who purchased this product should not use it and should contact the manufacturer or their local health authority for recall instructions, including safe product disposal.

The recalled product

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.
Manufacturer
Aire-Master of America Inc
Category
Drug — Hand Sanitizer
Hazard
Affected units
960

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Product Number 46112
  • Lots 722782 -exp 08/22

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 6 recalled by Aire-Master of America Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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