From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 6 Jun 2008 09:04:30 -0500 (CDT)
Subject: Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5)
Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5)
Fri, 06 Jun 2008 08:11:00 -0500
Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.
Updates: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 6 Jun 2008 12:46:52 -0500 (CDT)
Subject: CDER New 6/5/2008
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June 5, 2008
- Drugs to be Discontinued
- Information on Heparin Sodium Injection (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- New and Generic Drug Approvals
- Antara (fenofibrate) Capsules, Oscient Pharmaceuticals, Labeling Revision
- BARACLUDE (entecavir) Tablets, Bristol-Myers Squibb Company, Labeling Revision
- BARACLUDE (entecavir) Oral Solution, Bristol-Myers Squibb Company, Labeling Revision
- Carbidopa and Levodopa Tablets, Apotex Corp., Approval
- Carbinoxamine Maleate Tablets, Boca Pharmacal, Inc., Approval
- ChloraPrep (chlorhexidine gluconate and isopropyl alcohol) Sponge, Enturia, Inc., Formulation Revision
- Lovaza (omega-3-acid ethyl esters) Capsules, Reliant Pharmaceuticals, Inc., Labeling Revision
- Mirena (levonorgestrel) Intrauterine Device, Bayer Healthcare Pharmaceuticals, Inc., Labeling Revision
- Moexipril Hydrochloride Tablets, Apotex Corp., Approval
- OxyContin (oxycodone hydrochloride) Extended-Release Tablets, Purdue Pharma LP, Labeling Revision
- Potassium Chloride Extended-Release Capsules, Andrx Pharmaceuticals, LLC, Approval
- Propranolol Hydrochloride Tablets, Ipca Laboratories, Ltd., Approval
- Reclast (zoledronic acid) Injection, Novartis Pharmaceuticals Corp., New or Modified Indication
- SPRYCEL (dasatinib) Tablets, Bristol-Myers Squibb Co., Control Supplement
- Stavudine Oral Solution, Aurobindo Pharma USA, Inc., Tentative Approval
- Tradename To Be Determined (mesalamine) Delayed-Release Tablets, Procter & Gamble Pharmaceuticals, Approval
Updates: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 6 Jun 2008 14:05:18 -0500 (CDT)
Subject: FDA Announces New Labeling Changes for Regranex
FDA Announces New Labeling Changes for Regranex
Fri, 06 Jun 2008 13:25:00 -0500
The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01 percent (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.
Updates: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 6 Jun 2008 16:03:53 -0500 (CDT)
Subject: FDA Takes Action against Seafood Processing Company, Executives
FDA Takes Action against Seafood Processing Company, Executives
Fri, 06 Jun 2008 11:56:00 -0500
The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act.
Updates: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 6 Jun 2008 17:04:41 -0500 (CDT)
Subject: FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A
FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A
Fri, 06 Jun 2008 16:00:00 -0500
Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles.
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