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# IMC Sanitizer Illegal: FDA
- URL: https://www.fdaweb.com/imc-sanitizer-illegal-fda/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:26:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150821

IMC Wash-Free Hand Sanitizer, declared to be manufactured by Guangdong Kemei Pharmaceutical Technology Co., Shishan Foshan, China, is an unapproved new drug that is adulterated and misbranded, according to a 12/14 FDA [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/guangdong-kemei-pharmaceutical-technology-co-ltd-612090-12142021?ref=fdaweb.com). The letter says the sanitizer is adulterated because it is labeled to contain 75% ethanol but in laboratory testing contained an average of 35% ethanol and 32% methanol.

“This hand sanitizer is adulterated … in that the active ingredient, ethanol, was substituted wholly or in part with methanol, a dangerous chemical when in contact with human skin or ingested,” the letter says.

FDA says the company had informed the agency that it had not manufactured the products and had given its “FDA certificates” to a third party that likely had manufactured the sanitizer. The letter says FDA recommended the firm consider removing all of its hand sanitizer products currently in distribution in the U.S. and that while Guangdong Kemei agreed to support the recall of IMC hand sanitizer products, it has not yet committed to the recall.

The letter lists multiple misbranding violations and also recommends that the firm engage a qualified consultant to evaluate its operations and assist it in meeting current good manufacturing practice requirements.

Guangdong Kemei was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with a timetable for completing the actions.