Drug product
V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml), UPC 7 16053 70499 3; c) 33.8 fl. oz. (1000 ml) bottles: 716053704993; Manufactured by: Asiaticon S.A. de C.V. Conkar 62, Jardines del Ajusco. Tlalpan Cuidad de Mexico. 14200 ;
D-0116-2021
Product summary
- Event
- Event 86327
- Status
- Terminated
- Classification
- Class II
- Quantity
- 111,500 units
- Official record key
drug-enforcement:D-0116-2021
Official wording
Reason: Lack of CGMPs:
Code information: All lots.
Distribution pattern: Distributed in Texas
Derived failure modes
-
Manufacturing or process control
Lack of CGMPs