Drug & medication recalls Moderate risk

Panagel Hand Sanitizer 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 Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribut…
Recall number
D-0037-2021
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

Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016.

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