CDRH New Update, FDA Warning Letters, Cantaloupe,Glucose Monitoring System, Spokane Produce Recalls

Update : 1

Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: March 28, 2008

The following new items were added to the CDRH web pages on March 27, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.

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Update : 2

Subject: FDA Warning Letters Update

This information has recently been updated, and is now available.

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Update : 3

Subject: Bounty Fresh, LLC. Recalls Cantaloupe Because of Possible Health Risk (March 27)

Bounty Fresh, LLC. Recalls Cantaloupe Because of Possible Health Risk (March 27)
Fri, 28 Mar 2008 10:25:00 -0500

The recalled product was distributed nationwide to wholesalers and grocery stores. Whole cantaloupe fruits subject to this recall are packed three melons in a sleeve under the brand "Chestnut Hill Farms" and one melon per sleeve under the "Perfect Melon" brand. Individual melons are not labeled, but sleeves contain tags that say either "Perfect Melon" (one count) or "Chestnut Hill Farms" (3 count). Whole cantaloupe fruits subject to this recall were sold in boxes marked with the following text: "Cantaloupe, "Chestnut Hill Farms" (3 count) or "Perfect Melon" (one count), Produce of Honduras, Grown, Packed and Shipped by Agropecuaria Montelibano, San Lorenzo, Valle, Honduras". All boxes also contain the Chestnut Hill Farms logo.

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Update : 4

Subject: Chiquita Brands International, Inc. Recalls Whole Cantaloupes Grown by Agropecuaria Montelibano, Honduras, Due to Possible Health Risk (March 27)

Chiquita Brands International, Inc. Recalls Whole Cantaloupes Grown by Agropecuaria Montelibano, Honduras, Due to Possible Health Risk (March 27)
Fri, 28 Mar 2008 12:48:00 -0500

Chiquita Brands International, Inc. today announced a voluntary recall of cantaloupes grown, packed and shipped by an independent third-party grower, Agropecuaria Montelibano in Honduras. The product was distributed to customers nationwide and is being recalled because they have the potential to be contaminated with Salmonella.

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Update : 5

Subject: Recent Device Approvals Update: FreeStyle Navigator® Continuous Glucose Monitoring System

Information about the FreeStyle Navigator® Continuous Glucose Monitoring System has recently been posted to the FDA website, and is now available.

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Update : 6

Subject: FDA Seeks Civil Penalties from Calif. Device Maker

FDA Seeks Civil Penalties from Calif. Device Maker
Fri, 28 Mar 2008 14:19:00 -0500

The U.S. Food and Drug Administration (FDA) today announced it is seeking a 2.2 million dollar penalty against a California hearing aid manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.

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Update : 7

Subject: CDER New 3/28/2008

March 28, 2008

• New and Generic Drug Approvals
  • AUGMENTIN (amoxicillin/clavulanate potassium) Chewable Tablets, GlaxoSmithKline, Labeling Revision
  • AUGMENTIN (amoxicillin/clavulanate potassium) Powder for Oral Suspension, GlaxoSmithKline, Labeling Revision
  • AUGMENTIN (amoxicillin/clavulanate potassium) Chewable Tablets, GlaxoSmithKline, Labeling Revision
  • AUGMENTIN (amoxicillin/clavulanate potassium) Powder for Oral Suspension, GlaxoSmithKline, Labeling Revision
  • AUGMENTIN (amoxicillin/clavulanate potassium) Tablets, GlaxoSmithKline, Labeling Revision
  • Bethanechol Chloride Tablets, Lannett, Approval
  • Merrem I.V.(meropenem) Injection, AstraZeneca Pharma, Labeling Revision

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Update : 8

Subject: Spokane Produce Recalls Cut Cantaloupe Products Because of Possible Product Risk (March 28)

Spokane Produce Recalls Cut Cantaloupe Products Because of Possible Product Risk (March 28)
Fri, 28 Mar 2008 17:06:00 -0500

Spokane Produce, Inc. of Spokane, Washington is recalling Garden Patch, Yokes, and Rosauers Classic labels of various products of fresh cut and cut fruits containing cantaloupe, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Update : 9

Subject: Voluntary Recall on Honduran Cantaloupes Due to Potential Health Concerns (March 28)

Voluntary Recall on Honduran Cantaloupes Due to Potential Health Concerns (March 28)
Fri, 28 Mar 2008 18:59:00 -0500

Dole Fresh Fruit Company, a subsidiary of Dole Food Company, Inc., has voluntarily recalled all Honduran Cantaloupes grown, packed and shipped by an independent third-party grower, Agropecuaria Montelibano of San Lorenzo Valle, Honduras.

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Update : 10

Subject: MedWatch - Recall of Total Body Formula dietary supplements due to reports of hair loss, muscle cramps, diarrhea, joint pain and fatigue

The FDA notified consumers of a recall of, and advised them not to purchase or consume, the liquid dietary supplement products, Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The Florida Department of Health recently provided reports to the FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. FDA laboratories are analyzing samples of the products to identify the cause of the reactions.

Read the complete MedWatch 2008 Safety summary, including a link to the FDA press release, at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#TotalBody

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CDRH New Update, REMS,Cantaloupe Recalls , Risk Evaluation and Mitigation Strategy, Total Body Formula and Total Body Mega Formula

Update : 1

Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: March 27, 2008

The following new items were added to the CDRH web pages on March 26, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries
	Federal Register: Global Harmonization Task Force, Study Group 4; Final Document; Availability.
	Guidance for Industry: Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies (Companion Document)
	Guidance for Industry: Coronary Drug-Eluting Stents— Nonclinical and Clinical Studies

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Update : 2

Subject: Drug Information Update- Risk Evaluation and Mitigation Strategy (REMS)

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS. Some drug and biological products that previously were approved/licensed with risk minimization action plans (RiskMAPs) will now be deemed to have REMS.

There was a Federal Register published March 26, 2008, entitled Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies (REMS) for Purposes of the Food and Drug Administration Amendments Act of 2007. You can access this document at :

http://www.regulations.gov/fdmspublic/ContentViewer?bjectId=090000648040b1f8&disposition=attachment&contentType=html

For further information, please view the questions and answers at:

http://www.fda.gov/cder/regulatory/FDAAA/FR_QA.htm

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Update : 3

Subject: T.M. Kovacevich International, Inc. Recalls Cantaloupe Because of Possible Health Risk (March 25)

T.M. Kovacevich International, Inc. Recalls Cantaloupe Because of Possible Health Risk (March 25)
Thu, 27 Mar 2008 09:31:00 -0500

T.M. Kovacevich International, Inc. of Philadelphia, PA is recalling cantaloupes which it purchased from Agropecuaria Montelibano, a Honduran grower and packer, because the U.S. Food and Drug Administration ('FDA') has determined, based on current information, that cantaloupe fruit from this company has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Update : 4

Subject: FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics

FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics
Thu, 27 Mar 2008 15:07:00 -0500

The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a Federal Register notice published today.

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Update : 5

Subject: Food Label Helps Consumers Make Healthier Choices

Food Label Helps Consumers Make Healthier Choices
Thu, 27 Mar 2008 08:43:00 -0500

The food label allows you to compare foods quickly and easily to choose the ones that best fit your dietary needs.

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Update : 6

Subject: FDA Warns Consumers about Total Body Formula and Total Body Mega Formula

FDA Warns Consumers about Total Body Formula and Total Body Mega Formula
Thu, 27 Mar 2008 18:55:00 -0500

The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

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Update : 7

Subject: FDA Warns Consumers about Total Body Formula and Total Body Mega Formula (March 27)

FDA Warns Consumers about Total Body Formula and Total Body Mega Formula (March 27)
Thu, 27 Mar 2008 18:55:00 -0500

The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

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Update : 8

Subject: Simply Fresh Fruit Announces Nationwide Recall of Some Fresh Cut Fruit Products Containing Cantaloupe Due to Possible Salmonella Contamination (March 27)

Simply Fresh Fruit Announces Nationwide Recall of Some Fresh Cut Fruit Products Containing Cantaloupe Due to Possible Salmonella Contamination (March 27)
Wed, 26 Mar 2008 20:18:00 -0500

Simply Fresh Fruit, of Los Angeles, California is recalling selected fresh cut fruit products which may contain cantaloupe which has the potential to be contaminated with Salmonella.

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Update : 9

Subject: FDA MedWatch- FDA MedWatch- Singulair (montelukast)- Possible Association Between Use Of Singulair And Behavior/Mood Changes, Suicidality, And Suicide

FDA informed healthcare professionals and patients of the Agency's investigation of the possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a leukotriene receptor antagonist used to treat asthma and the symptoms of allergic rhinitis, and to prevent exercise-induced asthma. Patients should not stop taking Singulair before talking to their doctor if they have questions about the new information. Healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.
This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

Read the complete 2008 MedWatch Safety Summary, including a link to the FDA Early Communication About An Ongoing Safety Review regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Singulair

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Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 27 Mar 2008 14:07:25 -0500 (CDT)
Subject: FDA MedWatch- Regranex (becaplermin) Gel- Study Data Suggests Possible Increased Risk Of Death From Cancer In Diabetic Patients Using The Product

The FDA is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using Regranex (becaplermin) Gel, a skin product used to heal leg and foot ulcers. While the review is ongoing, the FDA recommends health care professionals discuss the potential risks and benefits of using Regranex with their patients.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

Read the complete 2008 Safety Summary, including a link to the FDA Early Communication About An Ongoing Safety Review regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Regranex

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Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 27 Mar 2008 14:25:33 -0500 (CDT)
Subject: FDA MedWatch- Ziagen (abacavir) and Videx (Didanosine)- Study Date Indicates A Higher Risk of Heart Attack In Patients Infected With HIV-1 Taking Ziagen Or Videx

The FDA issued an Early Communication about recent findings of The Data Collection on Adverse Events of Anti-HIV Drugs Study. Data analyses from this study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking Ziagen (abacavir) or Videx (didanosine) as part of their drug therapy. The study is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia. Patients in this study are being followed to evaluate the short and long term adverse effects of treatment with anti-HIV drugs. FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until the FDA’s review is complete, health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

Read the complete 2008 MedWatch Safety Summary, including a link to the FDA Early Communication About an Ongoing Safety Review regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#abacavir

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