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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Apr 2008 08:42:09 -0500 (CDT)
Subject: FDA Warning Letters Update
You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Apr 2008 09:05:26 -0500 (CDT)
Subject: Agriculture Department Warns Consumers of Tainted Raw Milk Sold By Clarion, Crawford County Dairies (April 7)
Agriculture Department Warns Consumers of Tainted Raw Milk Sold By Clarion, Crawford County Dairies (April 7)
Wed, 9 Apr 2008 09:00:00 -0500
Consumers who purchased raw milk from Piney Ridge dairy farm in New Bethlehem, Clarion County, and Clark and Elaine Duncan’s farm in Meadville, Crawford County, anytime after March 10 should discard it immediately due to the risk of Listeria Monocytogenes contamination.
Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Apr 2008 10:07:00 -0500 (CDT)
Subject: FDA Appoints Dr. Frank M. Torti to Senior Leadership Position
FDA Appoints Dr. Frank M. Torti to Senior Leadership Position
Wed, 9 Apr 2008 09:45:00 -0500
Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. today announced the appointment of Frank M. Torti, M.D., M.P.H. as the FDA's Principal Deputy Commissioner and first Chief Scientist.
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Apr 2008 13:07:57 -0500 (CDT)
Subject: Federal Authorities Seize More Than $100,000 of Unapproved Drugs Marketed as "Natural Supplements"
Federal Authorities Seize More Than $100,000 of Unapproved Drugs Marketed as "Natural Supplements"
Wed, 9 Apr 2008 12:14:00 -0500
At the request of the U.S. Food and Drug Administration, today U.S. Marshals seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Naturalë Super Plus, and Lady Shangai. Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction (ED), impotency, and/or to provide sexual enhancement, which caused them to be drugs under the Federal Food, Drug, and Cosmetic Act.
Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Apr 2008 15:05:50 -0500 (CDT)
Subject: North Aire Market Issues Allergy Alert on Possible Traces of Almonds in Chicken Dumpling Soup Mix (April 8)
North Aire Market Issues Allergy Alert on Possible Traces of Almonds in Chicken Dumpling Soup Mix (April 8)
Wed, 9 Apr 2008 14:34:00 -0500
North Aire Market of Shakopee, MN is recalling 99 boxes of Chicken Dumpling Soup Mix because they may contain undeclared traces of almonds. The 99 boxes were sold in various parts of the country primarily to specialty gift shops and through the company's web site under the brand, Maggie and Mary's Chicken Dumpling Soup Mix. The lot codes related to this recall are: 0730810, 0720810, 0910810, 0920811, 0920810, 0930810, 0980810, and are found on the bottom of the retail box.
Message: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Apr 2008 15:11:44 -0500 (CDT)
Subject: FDA MedWatch-Exubera (insulin human rDNA origin) Inhalation Powder-Prescribing Information Updated To Include Information About Primary Lung Malignancies In Patients In Clinical Trials
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Pfizer informed healthcare professionals and patients of updated safety information in the WARNINGS section of prescribing information for Exubera, a short-acting insulin you breathe in through your mouth using the Exubera inhaler that helps to control high blood sugar in adults with diabetes. There have been 6 newly diagnosed cases of primary lung malignancies in clinical trials among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking. Because of the limited availability of Exubera, healthcare professionals should seek alternative treatment options to maintain patients' glycemic control.
Read the complete 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter and Dear Patient Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#exubera
Message: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Apr 2008 16:11:28 -0500 (CDT)
Subject: FDA Finds Hazardous Levels of Selenium in Samples of "Total Body Formula" and"Total Body Mega Formula"
FDA Finds Hazardous Levels of Selenium in Samples of "Total Body Formula" and"Total Body Mega Formula"
Wed, 9 Apr 2008 15:20:00 -0500
The U.S. Food and Drug Administration announced today that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products.
Message: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Apr 2008 13:14:15 -0500 (CDT)
Subject: FDA MedWatch-Cubicin (daptomycin for injection)- Potentially Significant Impurity Isolated From Reconstituted Product Stored In ReadyMED Pumps
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Cubist Pharmaceuticals, Inc. informed healthcare professionals that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. MBT is used in the manufacture of rubber and has been reported to leach from rubber stoppers and syringe components into medicinal products in the past. Cutaneous exposure to MBT has been associated with dermal sensitization, and chronic administration of MBT to laboratory rodents has been associated with an increased risk of certain tumors. No MBT has been identified in reconstituted Cubicin in other standard types of infusion systems that have been tested. Healthcare professionals are advised to discontinue using ReadyMED elastomeric infusion pumps with Cubicin until the issue has been addressed.
Read the complete 2008 MedWatch Safety Summary, including a link to the Manufacturer's Dear Healthcare Professional Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#cubicin
Message: 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Apr 2008 15:51:24 -0500 (CDT)
Subject: FDA MedWatch-Neupro (rotigotine transdermal system)- Product Recalled Due To The Formation Of Rotigotine Crystals In The Patches
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Schwarz Pharma informed healthcare professionals and patients of the recall of Neupro, a transdermal delivery system worn on the skin and used to treat early stage Parkinson’s disease. The product is being recalled because of the formation of rotigotine crystals in the patches. When the drug crystallizes, less drug is available to be absorbed through the skin and the efficacy of the product may vary. Healthcare professionals should not initiate any new patients on Neupro and should begin to down-titrate all patients currently using the product per the guidelines in the product labeling. Patients should NOT abruptly discontinue therapy. Abrupt withdrawal of dopamine agonists has been associated with a syndrome resembling neuroleptic malignant syndrome or akinetic crises.
Read the complete 2008 MedWatch Safety Summary, including a link to the FDA's Drug Shortage Information Sheet regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#neupro
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