FDA recall D-0229-2021

Product

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.

Distribution

TX

Key facts

Status

Ongoing

Initiation date

2020-12-01

Report date

2021-01-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tonala, N/A, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0229-2021