Drug & medication recalls Moderate risk

Shine & Clean Hand Sanitizer gel recalled over undeclared methanol

Recall date
July 9, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Maquiladora Miniara Sa De Cv recalls Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara…
Recall number
D-1565-2020
FDA classification
Class II
Brand / firm
Maquiladora Miniara Sa De Cv
Sold / distributed
Distributed Nationwide in the USA

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

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