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.
D-0230-2021
Product summary
- Event
- Event 86898
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 43875 liters
- Official record key
drug-enforcement:D-0230-2021
Official wording
Reason: cGMP deviations: Product made at the same facility where product tested was sub-potent.
Code information: All Lots
Distribution pattern: TX
Derived failure modes
-
Manufacturing or process control
cGMP deviations