FDA recall D-0240-2021

Product

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.

Distribution

Nationwide USA and Canada

Key facts

Status

Terminated

Initiation date

2020-12-23

Report date

2021-02-03

Termination date

2023-09-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Spring Park, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0240-2021