D-0230-2021 Class II Ongoing
FDA drug recall D-0230-2021 was initiated by GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION on December 1, 2020 and is designated Class II. Reason for recall: cGMP deviations: Product made at the same facility where product tested was sub-potent. The recall status is ongoing. Affected quantity: 43875 liters.
Recall Details
- Product Type
- Drugs
- Report Date
- January 20, 2021
- Initiation Date
- December 1, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43875 liters
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.
Distribution Pattern
TX
Code Information
All Lots