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

In Brief: Ambix Laboratories

This article was originally published in The Tan Sheet

Executive Summary

Ambix Laboratories: Blue Gel pediculicide subject of Dec. 30 warning letter from FDA stating that the product is "misbranded" because it lacks directions and warnings required under the pediculicide final rule and does not declare the USP-established name of "pyrethrum extract." East Rutherford, N.J.-based Ambix, maker of Rx and OTC private label creams, gels and liquids, has issued several product recalls in past years and was subject to a 1993 seizure of OTC hydrocortizone cream for contamination with Staphylococcus aureus bacteria and concurrent regulatory action for noncompliance with Good Manufacturing Practices ("The Tan Sheet" Aug. 2, 1993, p. 15)...

You may also be interested in...



People In Brief

Perrigo promotes in pricing, planning

In Brief

Combe sells most of its OTC brands

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

PS086573

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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