FDA recall D-0116-2021

Asiaticon, SA de CV · Class II · 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 ;

Reason for recall

Lack of CGMPs:

Distribution

Distributed in Texas

Key facts

Status
Terminated
Initiation date
2020-08-25
Report date
2020-12-16
Termination date
2023-05-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ciudad De Mexico, N/A, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0116-2021