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Barry A. Friedman, PhD LLC

FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

VAGINA COSMETICS RECALLED FOR CONTAINING MICROORGANISMS AND BENZOCAINE

January 22, 2012 By Barry Friedman Leave a Comment

EFFECT OF MICROBIAL CONTAMINATION DIFFICULT TO ASSESS COMMENT USA Far Ocean Group issued a voluntary recall following FDA's laboratory analyses of "Vagifresh Gel" and "Vagifresh Ball".  The former contained benzocaine, while the later contained bacteria from a number of species to include Staphylococcus lentus, S. sciuri, Bacillus lentus, Alloiococcus otitis, … [Read more...]

INSIGHT PHARMACEUTICALS ISSUE VOLUNTARY NATIONWIDE RECALL DUE TO BACTERIAL CONTAMINATION

October 24, 2011 By Barry Friedman Leave a Comment

RECALL TO CONSUMER LEVEL BECAUSE OF POSSIBLE BURKHOLDERIA CEPACIA COMMENT Insight Pharmaceuticals recalled 34,092 bottles of Nostrilla Nasal Decongestant nasal spray because it may contain the bacteria Burkholderia cepacia.  This bacterium, known as a "specified" microorganism, has historically been a periodic … [Read more...]

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