The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1359-2022·Announced 2022-08-24

Foaming Hand Sanitizer Recalled for Water System Manufacturing Deficiency

Protect U Guard Foaming Hand Sanitizer is being recalled because it was manufactured with deionized water from a system lacking proper microbial controls. The affected 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA classified this as a Class II recall. While no illnesses or injuries have been reported, the manufacturing deficiency involves inadequate microbial control in the water system used to manufacture a product designed to be antimicrobial. This creates a theoretical but significant risk of contamination.

Plain-English summary

Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. bottles are being recalled. The affected product has Product Number 46111 and Lot 722781 with an expiration date of 09/22.

The recall was issued due to a manufacturing process deficiency. The product was manufactured using deionized water from a system that lacked appropriate microbial control measures. This deviation from Current Good Manufacturing Practice standards creates a potential risk of microbial contamination in the sanitizer.

The affected product was distributed in Florida, Illinois, Iowa, and New Jersey. Approximately 5,064 bottles are involved in this recall. Consumers who have this product should discontinue use and contact the manufacturer or their retailer for return and replacement instructions.

The recalled product

Product
Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606
Manufacturer
Aire-Master of America Inc
Category
Drug — Hand Sanitizer
Hazard
Affected units
5,064

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 46111
  • Lot 722781-exp 09/22

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 →

Related recalls

Same manufacturer · Aire-Master of America Inc

See all →

Same hazard · microbial contamination

See all →

Similar recalls