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, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis P…

Recall number

D-0038-2021

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, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-02, UPC 7401037205773.