PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 16, 2020 Initiated: July 9, 2020 #D-1565-2020

Product Description

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.

Details

Units Affected
245,500 bottles
Distribution
Distributed Nationwide in the USA
Location
Coyotepec

Frequently Asked Questions

What product was recalled?
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. Recalled by Maquiladora Miniara Sa De Cv. Units affected: 245,500 bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 16, 2020. Severity: Moderate. Recall number: D-1565-2020.