US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Dec 1, 2020 (6 years ago)

Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL)…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

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

Recalling firm
Gaza Proveedora De Servicios De Hospedaje Y Alimentacion
NDC code
76540-100-02
Origin
N/A, Mexico
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0229-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.