Protect U Guard Foaming Hand Sanitizer Ophardt recalled over manufacturing violations
- Recall date
- July 15, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Aire-Master of America Inc recalls Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Pro…
- Recall number
- D-1358-2022
- FDA classification
- Class II
- Brand / firm
- Aire-Master of America Inc
- Sold / distributed
- Florida, Illinois, Iowa, New Jersey
Why it was recalled
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
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