FDA recall D-0796-2021

Grupo Asimex de Mexico SA de CV · Class II · drug

Product

Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.

Reason for recall

CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.

Distribution

Distributor in FL who further distributed Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2020-08-14
Report date
2021-09-22
Termination date
2023-10-17
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-0796-2021