FDA recall D-1620-2020

AJR TRADING LLC · Class II · drug

Product

bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle, Hecho en Mexico por: AAA Cosmetica S.A. DE C.V. Recursos Hidraulicos No. 1 Secc. A, Col La Loma Zona Industrial, Tlalnepantla de Baz C.P. 54060 Edo. Mexico. UPC 7 502272 12108 5

Reason for recall

CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.

Distribution

Distributed in Florida

Key facts

Status
Terminated
Initiation date
2020-09-03
Report date
2020-09-30
Termination date
2023-10-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Coral Gables, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1620-2020