Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing recalled over manufacturing violations

Recall date

December 1, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION recalls Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal…

Recall number

D-0229-2021

FDA classification

Class II

Brand / firm

GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION

Sold / distributed

TX

Why it was recalled

cGMP deviations: Product made at the same facility where product tested was sub-potent.

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

What was recalled

Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rural Rd.,Tempe AZ, 85283, Made in Mexico by: Gaza Proveedora De Servicios De Hospedaje y Alimentos S.A. de C.V., UPC 8 64972 00049 5, NDC 76540-100-02