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.
Recall initiated: 20201201
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated