Laavo Clean, S.A. de C.V. Warning Letter Details

Summary

Laavo Clean, S.A. de C.V., a Mexican drug manufacturer, was warned that its hand sanitizer products labeled as containing 0.13% benzalkonium chloride (BZK) were adulterated because testing of batches detained at the U.S. border revealed strength variations exceeding acceptable limits—one product contained 115% of the labeled claim while another contained only 92.7%, both falling outside USP specifications of 93.0-107.0%. The adulteration violations involved two products: Instant Hand Sanitizer LaavoClean without Alcohol and Instant Hand Sanitizer LaavoClean KIDS without Alcohol, which were rejected upon attempted importation into the United States due to these strength deficiencies and exceedances.