FDA News Digest May 17, 2004 _________________________________________________
THIS WEEK'S NEWS -- Adult Tylenol Found in Children's Grape Chewable Motrin Prompts Recall -- May 18-19 Forum Spotlights Science Achievements, Collaborations -- FDA Offers Patient Information on Three Recently Approved Medical Devices -- Recalls/Market Withdrawals -- Congressional Testimony _______________________________________________________________ Adult Tylenol Found in Children's Grape Chewable Motrin Prompts Recall McNeil Consumer & Specialty Pharmaceuticals is recalling one manufacturing lot of Children's Motrin Grape Chewable Tablets that was found to contain adult-strength Tylenol Geltabs. The problem is thought to be due to a packaging error. Use of this adult product could cause an overdose in children. http://www.fda.gov/oc/po/firmrecalls/mcneil05_04.html May 18-19 Forum Spotlights Science Achievements, Collaborations Leading scientists from FDA, other agencies, and research organizations will gather in Washington, D.C., May 18 and 19 for the FDA Science Forum to examine scientific developments and regulatory concerns in public health. The forum will showcase and award scientific achievements, facilitate discussions, and promote research collaborations. Included in this year's Forum for the first time is a free public session on "Communicating FDA Science to the Public," which includes talks on children in clinical trials and food safety. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01289.html FDA Offers Patient Information on Three Recently Approved Medical Devices FDA's Center for Devices and Radiological Health has created consumer information Web pages for three different medical devices recently approved for treating various disorders. The pages, linked on the following list, have brief descriptions of the devices, what they are intended to do and how they should and should not be used. -- Oculaid and Stableyes Capsular Tension Rings (for cataracts) http://www.fda.gov/cdrh/MDA/DOCS/P030023.html -- Precision Spinal Cord Stimulator (for chronic pain) http://www.fda.gov/cdrh/MDA/DOCS/p030017.html -- Oxford Meniscal Unicompartmental Knee System (for knee disorders) http://www.fda.gov/cdrh/MDA/DOCS/p010014.html _______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked pages for more information. DU Brand Nasal Decongestant Spray (possible contamination with Burkholderia cepacia bacteria) http://www.fda.gov/bbs/topics/news/2004/NEW01066.html Stonington Sea Products Cold Smoked Salmon; 4-, 8-, and 12-oz. sizes and bulk in sliced and unsliced sides (possible contamination with Listeria monocytogenes bacteria) http://www.fda.gov/oc/po/firmrecalls/stonington05_04.html Essensia Milk Chocolate Chunk Cookies; 7.2-oz. size (undeclared macadamia nuts) http://www.fda.gov/oc/po/firmrecalls/colonial05_04.html Tecan Clinical Workstation (possible software and operational problems) http://www.fda.gov/oc/po/firmrecalls/roche05_04.html Precise Rx Nitinol Stent Transhepatic Biliary System (device maker Cordis Corp. is recalling revised instructions for use) http://www.fda.gov/cdrh/recalls/recall-050404.html For a listing of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html _______________________________________________________________ CONGRESSIONAL TESTIMONY FDA Director of Oncology Drug Products Richard Pazdur, M.D.; before the House Committee on Government Reform; subject: "Harnessing Science: Advancing Care by Accelerating the Rate of Cancer Clinical Trial Participation" (May 13) http://www.fda.gov/ola/2004/clinicaltrials0513.html _______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be May 24. To leave this list at any time, send an e-mail to [EMAIL PROTECTED] In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
