In Brief: Lanax warning letter

Executive Summary

Lanax warning letter: Carma Labs receives notice from FDA that Lanax Ointment, a hemorrhoid treatment, fails to meet the requirements of the anorectal OTC monograph. Two ingredients, phenol and salicylic acid, are not considered safe and effective for treatment of hemorrhoids, FDA says. In addition, the product fails to bear appropriate warnings, directions and a statement of identity. Also, a January FDA inspection found "deviations" from the CGMP regs, including the failure of production and packaging records to show the amount of product packaged under the Lanex label...