FDA News Digest August 16, 2004 _______________________________________________ IN THIS WEEK'S ISSUE -- Two Drugs OK'd for Treating Internal Contamination from Radiation -- FDA Seeks Injunction Against Utah Medical Device Maker -- Illegally Compounded Horse Drugs Seized from Kentucky Company -- FDA, Customs Revise Enforcement Strategy on Prior Notice for Imported Foods -- Recalls/Market Withdrawals -- Public Meetings ____________________________________________________________ Two Drugs OK'd for Treating Internal Contamination from Radiation FDA has approved pentetate calcium trisodium injection (Ca-DTPA) and pentetate zinc trisodium injection (Zn-DTPA) for treating internal contamination from the radioactive elements plutonium, americium, and curium. Such contamination could occur through a terrorist attack using a "dirty bomb" to disperse the radiation or through an accidental release. The drugs increase the elimination of the radioactive elements from the body. http://www.fda.gov/bbs/topics/news/2004/NEW01103.html FDA Seeks Injunction Against Utah Medical Device Maker FDA is seeking a court order that would prohibit Utah Medical Products, Inc., from manufacturing and distributing medical devices until the company corrects problems with its manufacturing practices that potentially put patients at risk. The company makes devices for use in obstetrics, gynecology, neonatal intensive care, blood pressure monitoring and other areas. FDA has issued repeated warnings to the firm to bring its manufacturing processes up to regulatory standards. http://www.fda.gov/bbs/topics/news/2004/NEW01102.html Illegally Compounded Horse Drugs Seized from Kentucky Company U.S. marshals, at FDA's request, have seized various illegally compounded horse drugs from BET Pharm in Lexington, Ky. Because the drugs are not approved and their safety and effectiveness are unknown, they could pose a health risk to horses. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01305.html FDA, Customs Revise Enforcement Strategy On Prior Notice for Imported Foods FDA and the U.S. Customs and Border Protection have revised a compliance policy guide that describes how the agencies will enforce requirements for companies to give FDA prior notice of foods being imported into the United States. The revisions include clarification of how the agencies will handle violations of the prior notice rule. FDA receives about 160,000 prior notice submissions a week. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01304.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Certain Healthy Way sprouted grain breads (may contain small stones) http://www.fda.gov/bbs/topics/news/2004/NEW01101.html Frizz-Ease 5-Minute Manager Blow-Dry Styling Spray; 6.7 fluid oz. (200 ml) pump spray (may contain yeast and mold) http://www.fda.gov/oc/po/firmrecalls/frieda08_04.html Wing Shing Dried Lily Flower (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/murray08_04.html For a list 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 To access the RSS feed of FDA recalls information, go to http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml ______________________________________________________________ PUBLIC MEETINGS Sept. 20-24 -- 2004 PDA/FDA Joint Regulatory Conference; Washington, D.C. http://www.pda.org/pdafda2004/index.html For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be August 23. To leave this list at any time, send an e-mail to LISTSERV@xxxxxxxxxxxx In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
