Dihoma warning letter
This article was originally published in The Tan Sheet
Executive Summary
Protect U-2000 aerosolized pediculicide with actives pyrethrins extract and piperonyl butoxide for treatment of "head lice, body lice, crab lice and chiggers" is a drug covered by the final rules for pediculicides, FDA says in a March 18 warning letter. The rule classifies pyrethrins and piperonyl butoxide in aerosol dosage form as nonmonograph and also does not allow any claims for the treatment of chiggers, FDA says. Mullins, S.C.-based Dihoma Chemical and Manufacturing also is cited in the letter for "numerous significant" deviations from GMP regs