Drug product
Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01 UPC 2 000000 531151); b) 1 gal (3.76L) (NDC 69912-008-02 UPC 2 000000 531144) bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Caracol, 64810, Monterrey, N.L., Mexico Nanomateriales S.A. DE C.V.
D-1592-2020
Product summary
- Event
- Event 86333
- Status
- Terminated
- Classification
- Class II
- Quantity
- a)19,440 liters b) 25,917 gallon
- Official record key
drug-enforcement:D-1592-2020
Official wording
Reason: GMP Deviations: Potential to contain 1-propanol.
Code information: All lots
Distribution pattern: CA, NY and Mexico
Derived failure modes
-
Manufacturing or process control
GMP Deviations