FDA recall D-0230-2021

GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION · Class II · drug

Product

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.

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-0230-2021