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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)...

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