PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: January 20, 2021 Initiated: December 1, 2020 #D-0229-2021

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.

Details

Units Affected
26,000 liters
Distribution
TX
Location
Tonala, N/A

Frequently Asked Questions

What product 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. Recalled by GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION. Units affected: 26,000 liters.
Why was this product recalled?
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 20, 2021. Severity: Moderate. Recall number: D-0229-2021.