FDA Flags Hand Sanitizer

Corporativo Bureli S.A. de C.V., Tepetlacalco, Mexico, has been issued a warning letter by the US Food & Drug Administration (FDA) after the US agency conducted testing of a consumer antiseptic rub drug product (a consumer hand sanitizer), labeled as Soho Fresh Hand Sanitizer, that was manufactured at the company’s facility. Following an attempt to import Soho Fresh Hand Sanitizer into the US, it was detained and refused admission at the border. 
 
The results of the FDA laboratory testing of a batch of this product detained at the border demonstrate that this drug product declared to be manufactured at your facility is adulterated within the meaning of section 501(d)(2) of the Federal Food, Drug, and Cosmetic Act, In addition, this product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, in that the substitution demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements, said FDA.
 
Soho Fresh Hand Sanitizer is labeled to contain 70% of the active ingredient ethyl alcohol (ethanol), however, the FDA laboratory testing of a batch of this product detained at the border found that the product contained an average of <0.25% ethanol and an average of 70% methanol volume/volume. 

You can access FDA's warning letters here.