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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 6 May 2008 07:05:41 -0500 (CDT)
Subject: Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2)
Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2)
Tue, 6 May 2008 06:25:00 -0500
Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash.
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 6 May 2008 07:49:59 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: May 6, 2008 |
The following new items were added to the CDRH web pages on May 5, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | 510(k) Final Decisions - April 2008 |  |
Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 6 May 2008 13:03:51 -0500 (CDT)
Subject: Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled
Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled
Tue, 6 May 2008 12:25:00 -0500
The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007.
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 6 May 2008 16:00:15 -0500 (CDT)
Subject: Recent Device Approvals: Thoratec HeartMate II Left Ventricular Assist System
You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about the Thoratec HeartMate II Left Ventricular Assist System (LVAS) has recently been posted to the FDA website, and is now available.
Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 6 May 2008 20:03:13 -0500 (CDT)
Subject: Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6)
Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6)
Tue, 6 May 2008 18:30:00 -0500
Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution.
Message: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 6 May 2008 08:05:39 -0500 (CDT)
Subject: FDA MedWatch - The May 2008 FDA Patient Safety News Is Now Available
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FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
Stories in the May 2008 edition include:
FDA Licenses New Hemophilia Treatment
Xyntha is produced without additives from human or animal material, which can further minimize the risk of infection...
Unsafe Use of Extended-Release Tussionex Suspension
Overdose of long-acting hydrocodone cough suppressant can result in respiratory depression and death...
Liver Injury with Tysabri (natalizumab)
Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury...
Updated Labeling Changes for Tamiflu (oseltamivir phosphate) and Relenza (zanamivir)
Patients with influenza should be closely monitored for signs of abnormal behavior...
New Instructions for Using Talecris IG Syringes
How to use HyperRAB S/D and GamaSTAN S/D 2 mL syringes properly in certain circumstances...
Hepatotoxicity with Prezista (darunavir)
Appropriate laboratory testing should be conducted before starting treatment and patients should also be monitored during treatment...
Information on Mortality Rates with the AneuRx Stent Graft System
Patients should meet the appropriate risk-benefit profile...
Mistakenly Swallowing Inhaler Capsules
Respiratory problems will not be treated if patients mistakenly take the capsules orally rather than with an inhaler...
Choosing the Correct Test Strip for a Blood Glucose Meter
Using the wrong strip in any brand of blood glucose meter could result in erroneous readings or no readings at all...
For more
Message: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 6 May 2008 10:36:07 -0500 (CDT)
Subject: FDA MedWatch- Cardinal Health Alcohol-Free Mouth- Product Recalled Because Of the Presence Of Burkholderia Cepacia
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Hydrox Labs issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash because the product was found to contain Burkholderia cepacia (B. cepacia). The affected product lot number is 26228. B. cepacia poses little medical risk to healthy individuals. However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with this organism. Consumers and facilities with the recalled alcohol-free mouthwash should stop using the product and contact Cardinal Health for instructions on how to return the product.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Cardinal
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