Multiple Violations in Herbacil Antiseptic Hand Sanitizer

FDA says its testing of Herbacil Antiseptic Hand Sanitizer produced by Broncolin, Iztacalco, Mexico, found that the product is adulterated and misbranded. A 12/21 Warning Letter says agency laboratory testing determined that the product contained large amounts of methanol, even though it was labeled to contain ethanol.

The letter notes that the company initiated a 7/27/20 recall of its Herbacil in the U.S. due to the presence of undeclared methanol. It also lists adulteration, unapproved new drug, and misbranding violations.

FDA recommends says that if the company intends to resume manufacturing drugs for the U.S. market, it engage a qualified consultant to assist it in meeting CGMP requirements.

Broncolin was told to respond with a list of actions it has taken to address the violations and prevent their recurrence, with a timetable for completing the actions.