Drug & medication recalls Moderate risk

Avant 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 Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Br…
Recall number
D-1356-2022
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

Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253

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