Zapien Productos Hand Sanitizer Gel Antibacterial 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 Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-…

Recall number

D-0230-2021

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

Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala, Jalisco, Mexico, UPC: 7 501700 623504, NDC numbers: 76938-001-01, 76938-001-02, 76938-001-03.