FDA recall D-0117-2021

Asiaticon, SA de CV · Class II · drug

Product

Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med Products, Inc. Burlington, WI 53105 Made in Mexico by Asiaticon S.A. de C.V. Conkal No. 62, Mexico, Ciudad de Mexico 14200, Mexico NDC: 75192-600-02 UPC 7 503019 005002

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-0117-2021