PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: January 20, 2021 Initiated: December 1, 2020 #D-0230-2021

Product Description

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.

Details

Units Affected
43875 liters
Distribution
TX
Location
Tonala, N/A

Frequently Asked Questions

What product was recalled?
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.. Recalled by GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION. Units affected: 43875 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-0230-2021.