Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Dis...
FDA Recall #D-0229-2021 — Class II — December 1, 2020
Product Description
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
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
26,000 liters
Distribution
TX
Code Information
All Lots
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated