Drug & medication recalls Moderate risk

Genesis Hand Sanitizer Gel recalled over manufacturing violations

Recall date
September 11, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Genesis Partnership Company SA recalls Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis…
Recall number
D-0039-2021
FDA classification
Class II
Brand / firm
Genesis Partnership Company SA
Sold / distributed
Nationwide in the U.S.

Why it was recalled

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-04, UPC 7401037203427.

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