Update : 1
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | 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. |  |  |
Update : 2
Subject: FDA Warning Letters Update
This information has recently been updated, and is now available.
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.
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.
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.
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.
Update : 7
Subject: CDER New 3/28/2008
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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
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.
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.
Update : 10
Subject: MedWatch - Recall of Total Body Formula dietary supplements due to reports of hair loss, muscle cramps, diarrhea, joint pain and fatigue
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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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