Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C....
FDA Recall #D-0230-2021 — Class II — December 1, 2020
Product Description
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.
Reason for Recall
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Recalling Firm
GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION — Tonala, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
43875 liters
Distribution
TX
Code Information
All Lots
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated