FDA recall D-1565-2020

Maquiladora Miniara Sa De Cv · Class II · drug

Product

Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carrerera Teoloyucan Huehuetoca km: 22 S/N La Planada Mexico C.P.: 54665 NDC 76753-001-01

Reason for recall

CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.

Distribution

Distributed Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2020-07-09
Report date
2020-09-16
Termination date
2024-04-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Coyotepec, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1565-2020