Updated Daily! brought to you by PC SOLUTIONS / DMEFREE visit us at www.dmefree.com

Monday, June 15, 2009

FDA Consumer Alert: Warning Consumers of a Tainted Skin Sanitizer

 FDA Consumer Alert: Warning Consumers of a Tainted Skin Sanitizer
 
Following an announcement by the U. S. Food and Drug Administration (FDA) warning consumers of a tainted skin sanitizer, the Centers for Medicare & Medicaid Services (CMS) is advising health care providers and consumers not to use skin products made by Clarcon Biological Chemistry Laboratory.  Clarcon is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection.
 
Consumers and providers are being warned to not use any Clarcon products and to throw these products away in household refuse.
 
FDA analyses of several samples of Clarcon products revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues.  Such infections may need medical or surgical attention, and may result in permanent damage. Examples of products that should be discarded include:
             Citrushield Lotion
            Dermasentials DermaBarrier
            Dermassentials by Clarcon Antimicrobial Hand Sanitizer
            Iron Fist Barrier Hand Treatment
            Skin Shield Restaurant
            Skin Shield Industrial
            Skin Shield Beauty Salon Lotion
            Total Skin Care Beauty
            Total Skin Care Work
 
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
--Online 
--Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: 800-FDA-0178
--Phone: 800-FDA-1088

For more information:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm164845.htm
 
-----------------------------------------------------------------------------------------------------------------
Note:  If you have problems accessing any hyperlink in this message, please copy and paste the URL into your Internet browser. 
If you received this message as part of the All FFS Providers listserv, you are currently subscribed to one of eighteen Medicare Fee-For-Service provider listservs.  If you would like to be removed from all NIH listservs, please go to (https://list.nih.gov/LISTSERV_WEB/signoff.htm) to unsubscribe.  If you would like to unsubscribe from a specific provider listserv, please go to (https://list.nih.gov/cgi-bin/show_list_archives) to unsubscribe or to leave the appropriate listserv. Please DO NOT respond to this email. This email is a service of CMS and routed through an electronic mail server to communicate Medicare policy and operational changes and/or updates. Responses to this email are not routed to CMS personnel. Inquiries may be sent by going to (http://www.cms.hhs.gov/ContactCMS). Thank you.

About this Blog

This blog shows most if not all of the announcements sent via the various email Mailservers.