IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distribu...
FDA Recall #D-0240-2021 — Class II — December 23, 2020
Product Description
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
Reason for Recall
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Recalling Firm
Shane Erickson Inc — Spring Park, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
42,157 bottles
Distribution
Nationwide USA and Canada
Code Information
Lot: MFG: 2020/05/10 L/N: 20200510-3
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated