Drug 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

D-0240-2021

December 23, 2020

Class II

Product summary

Firm: Shane Erickson Inc
Event: Event 87037
Status: Terminated
Classification: Class II
Quantity: 42,157 bottles
Official record key: drug-enforcement:D-0240-2021

Official wording

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

Code information: Lot: MFG: 2020/05/10 L/N: 20200510-3

Distribution pattern: Nationwide USA and Canada

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations
Potency or specification failure
reason.potency_specification_failure · v1.0.0

subpotent