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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 15 Feb 2008 06:01:04 -0600 (CST)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: February 15, 2008 |
The following new items were added to the CDRH web pages on February 14, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Draft Guidance for Industry and FDA Staff: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses |  |  |
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 15 Feb 2008 14:05:22 -0600 (CST)
Subject: FDA Proposes Guidance for Dissemination of Information on Unapproved Uses of Medical Products
FDA Proposes Guidance for Dissemination of Information on Unapproved Uses of Medical Products
Fri, 15 Feb 2008 13:09:00 -0600
The U.S. Food and Drug Administration (FDA) today issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.
Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 15 Feb 2008 14:05:24 -0600 (CST)
Subject: Sherwood Brands Announces Nationwide Recall of Pokemon Branded Valentine Cards and Pops Because They May Contain Metal Fragments (Feb. 14)
Sherwood Brands Announces Nationwide Recall of Pokemon Branded Valentine Cards and Pops Because They May Contain Metal Fragments (Feb. 14)
Fri, 15 Feb 2008 12:02:00 -0600
Sherwood Brands LLC is voluntarily recalling approximately 400,000 packages of Pokemon branded "Valentine Cards and Pops" (Item# 073964209109 and Item# 073964289804), because of reports that metal fragments were found in two lollipops purchased in Florida. There are no reports of injury. People who bite into or swallow a metal fragment could possibly be injured.
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 15 Feb 2008 14:06:39 -0600 (CST)
Subject: PriCara Recalls 25 mcg/hr DURAGESIC (fentanyl transdermal system) CII Pain Patches (Feb. 12)
PriCara Recalls 25 mcg/hr DURAGESIC (fentanyl transdermal system) CII Pain Patches (Feb. 12)
Fri, 15 Feb 2008 12:02:00 -0600
PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. said today that all lots of 25 microgram/hour (mcg/hr) DURAGESIC (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recalled patches all have expiration dates on or before December 2009, and all are manufactured by ALZA Corporation, an affiliate of PriCara. The recall is being conducted in cooperation with the U.S. Food and Drug Administration. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also are being recalled.
Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 15 Feb 2008 17:04:24 -0600 (CST)
Subject: Dreyer's Issues Voluntary Recall of Slow Churned Light Caramel Delight and Butter Pecan Ice Cream Flavors for Undeclared Pecans (Jan. 22)
Dreyer's Issues Voluntary Recall of Slow Churned Light Caramel Delight and Butter Pecan Ice Cream Flavors for Undeclared Pecans (Jan. 22)
Fri, 15 Feb 2008 15:12:00 -0600
The potentially affected cartons are the 1.75-quart size of Dreyer's Slow Churned Light Caramel Delight and Slow Churned Light Butter Pecan ice cream. The sides of the Slow Churned Light cartons identify the flavor as Caramel Delight, but the carton lids identify it as Butter Pecan. The actual flavor of the ice cream may be Butter Pecan erroneously packaged in Caramel Delightcartons, so Dreyer's is recalling the ice cream to avoid any confusion among consumers who may be allergic to pecans.
Message: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 15 Feb 2008 17:04:47 -0600 (CST)
Subject: Rocky Mountain Popcorn Company Issues Recall of Low Fat Caramel Popcorn (in the green bag) 9 oz. (Feb. 11)
Rocky Mountain Popcorn Company Issues Recall of Low Fat Caramel Popcorn (in the green bag) 9 oz. (Feb. 11)
Fri, 15 Feb 2008 15:42:00 -0600
Rocky Mountain Popcorn Company, Centennial, CO is voluntarily initiating a nationwide recall of 1,603 bags of Low Fat Caramel 9 oz. Popcorn (in the green bag). This recall is on the Low Fat variety only. An ingredient in this product has been found to contain a trace amount of tree nuts, which potentially could cause an allergic reaction to any person with a tree nut allergy.
Message: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 15 Feb 2008 18:04:34 -0600 (CST)
Subject: Nutri-Foods Recalls "Organic Sesame Seeds Natural - Unhulled" Because of Possible Health Risk (Feb. 15)
Nutri-Foods Recalls "Organic Sesame Seeds Natural - Unhulled" Because of Possible Health Risk (Feb. 15)
Fri, 15 Feb 2008 16:12:00 -0600
The product comes in a .50 pound clear plastic package with a product SKU #170 at the top and a "packed on" date of December 28. This product was sold from circa December 15, 2007 through January 28, 2008.
Message: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 15 Feb 2008 14:55:13 -0600 (CST)
Subject: FDA MedWatch - Duragesic 25 mcg/hr (fentanyl transdermal system) Pain Patches - Recall because some patches may have a cut edge
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PriCara and Sandoz Inc. announced a nationwide recall of all lots of 25 mcg/hr Duragesic Patches sold in the United States. The product is being recalled because the patches may have a cut along one side of the drug reservoir within the patch which may result in the possible release of fentanyl gel that may expose patients or caregivers directly to fentanyl gel on the skin. Fentanyl is a potent Schedule II opioid medication and exposure to the gel may lead to serious adverse events, including respiratory depression and possible overdose, that may be fatal. Patches with a cut edge should not be used. These recalled patches have expiration dates on or before December 2009 and are all manufactured by ALZA Corporation.
Read the complete 2008 MedWatch Safety Summary, including a link to the FDA Firm Press Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Duragesic
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