Drug & medication recalls Moderate risk

IMC Wash-Free Hand Sanitizer recalled over manufacturing violations

Recall date
December 23, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Shane Erickson Inc recalls IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shorel…
Recall number
D-0240-2021
FDA classification
Class II
Brand / firm
Shane Erickson Inc
Sold / distributed
Nationwide USA and Canada

Why it was recalled

CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained 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

IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as a) SAFE-GUARD Products International, b) Safe-WAY JEVCO Wash-Free Hand Sanitizer, c) TRACTION CAPITAL, d) United States Census 2020. UPC 8 19845 00598 5

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