Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

You may also be interested in...



Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

People In Brief

Perrigo promotes in pricing, planning

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

Topics

UsernamePublicRestriction

Register

LL009864

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel