Yearly Archives 2012

FDA and CDC Identified bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC. NOT Custodiol HTK

http://www.fda.gov/Drugs/DrugSafety/FungalMeningitis/default.htm CDC and FDA Laboratory-Confirmed Organisms from Product Samples Laboratory-Confirmed Organisms from Product Samples Associated with NECC Recalled Lots of Betamethasone, Cardioplegia, and Triamcinolone Solutions Medication Lot Number Bacterial and Fungal Contamination Betamethasone 6 mg/mL injectable –5 mL per vial 08202012@141 Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp., Bacillus niacini, Kocuria rosea, Bacillus lentus Betamethasone 6 mg/mL injectable –5 mL per vial 07032012@22 Bacillus niabensis, Bacillus circulans Betamethasone 12 mg/mL injectable – 5 mL per vial 07302012@52 Bacillus lentus, Bacillus circulans, Bacillus niabensis, Paenibacillus barengoltzii/timonensis Betamethasone 6mg/mL injectable – 5 mL per vial 08202012@44 Bacillus lentus, Bacillus
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Custodiol HTK noted under Best Practices

Englesbe-Reducing Ped Liver Tx Complications Improvement Initiatives 9-12 Check out Step 3b: Best Practice Report: Biliary Complications Liver flush with histidine-tryptophan-ketoglutarate (HTK) solution. American Journal of Transplantation 2012; 12: 2301–2306 Reducing Pediatric Liver Transplant Complications: A Potential Roadmap for Transplant Quality Improvement Initiatives Within North America  M. J. Englesbea,∗, B. Kellyb , J. Gossc , A. Fecteaud , J. Mitchelle , W. Andrewsf , G. Krapohla , J. C. Mageea , G. Mazariegosg , S. Horslenh and J. Bucuvalasi a Department of Surgery, University of Michigan, Ann Arbor, MI, b Department of Surgery, Vanderbilt University, Nashville, TN, c Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX,
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Order Custodiol HTK from Essential Pharmaceuticals, and get Custodiol HTK. No confusion and Peace of Mind.

With Custodiol HTK – you KNOW what product you are getting – no question.  Interesting lawsuit. Organ Recovery Systems, Inc. v. Preservation Solutions, Inc., 2012 WL 2577500 (N.D. Ill.) ORS sued defendants for breach of contract, false advertising and unfair competition under the Lanham Act, deceptive trade practices, and consumer fraud.  Some defendants counterclaimed.  ORS sells solutions that are used to preserve kidneys during transplant procedures. ORS attempted to improve one solution’s packaging and shelf life and entered into a contract with PSI to have PSI assist with testing, manufacturing and obtaining regulatory approval for the product, known as KPS–1.
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