Class II · Moderate risk
Common Sense Fragrance Free Hand Sanitizer
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Protect U Guard Foaming Hand Sanitizer
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606
- Recalling firm
- Aire-Master of America Inc
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1359-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Aire-Master of America Inc
All 2022 recalls
Class II · Moderate risk
Protect U Guard Foaming Hand Sanitizer Ophardt
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Stage 2-Ophardt Foaming Hand Sanitizer
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Avant Foaming Hand Sanitizer Ophardt
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Other microbial contamination recalls from 2022
All microbial contamination recalls
Class I · High risk
Easy Care First Aid 10 Person 2009 ANSI
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class I · High risk
CVS First Aid Home
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class I · High risk
Easy Care First Aid 25 Person 2009 ANSI
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class I · High risk
Easy Care First Aid Class A ANSI 25 Person
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
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