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Barry A. Friedman, PhD LLC

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

FDA advises consumers not to use Blissful Remedies kratom products due to bacterial contamination 7/05/2018

July 8, 2018 By Barry Friedman Leave a Comment

 FDA  advises consumers not to use Blissful Remedies kratom products due to bacterial contamination.  The products are sold by World Organix LLC, Las Vegas, Nevada.  FDA laboratory analysis found that the products are contaminated with high counts of various bacteria that can cause infections, including Salmonella, Clostridium difficile, Klebsiella pneumoniae and Pseudomonas … [Read more...]

NUTEK DISPOSABLES, INC ISSUES ALERT DUE TO POTENTIAL BACTERIA IN BABY WIPES (RECALL – 10/25/14)

December 3, 2014 By Barry Friedman Leave a Comment

FOR IMMEDIATE RELEASE — Oct. 25, 2014 — MCELHATTAN, PA — Nutek Disposables, Inc. of McElhattan, PA has initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the brand names Cuties, Diapers.com, Femtex, Fred's, Kidgets, Member's Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings, because some … [Read more...]

WHITE & BLUE LION CONDUCT NATIONWIDE RECALL OF TATTOO INK, TATTOO NEEDLES, AND TATTOO KITS DUE TO MICROBIAL CONTAMINATION (7/15/14)

September 21, 2014 By Barry Friedman Leave a Comment

White & Blue Lion, Inc, City of Industry, CA recently recalled all lots of tattoo inks and tattoo needles due to pathogenic bacterial contamination.  The recall indicated that the “use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection.  The recall includes all tattoo ink, tattoo needles, … [Read more...]

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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