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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 24 Mar 2008 08:03:27 -0500 (CDT)
Subject: Charlie's Produce Spokane Recalls Cut Cantaloupe Products Because of Possible Health Risk (Mar. 22)
Charlie's Produce Spokane Recalls Cut Cantaloupe Products Because of Possible Health Risk (Mar. 22)
Mon, 24 Mar 2008 08:37:00 -0500
The products containing cantaloupe were distributed in Eastern Washington, Idaho, and Montana to retail stores, delis, and foodservice institutions. Products are branded with the Charlie's Produce name and logo, in a hard plastic clamshell, with a Use By date of 3 07 through 3 29 stamped on the bottom of the container.
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 24 Mar 2008 11:50:20 -0500 (CDT)
Subject: Inflammatory Mass Formation Associated with Medtronic Implantable Infusion Pumps - Medical Device Safety
Medtronic Inc. has updated the labeling for certain models of the SynchroMed El, SynchroMed II and IsoMed implantable infusion pumps because of an increase in the reported rate of inflammatory mass formations. The labeling updates include patient management and treatment recommendations.
Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 25 Mar 2008 05:37:41 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: March 25, 2008 |
The following new items were added to the CDRH web pages on March 24, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. |  |  |
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 25 Mar 2008 09:15:11 -0500 (CDT)
Subject: Medical Device Recalls: Medtronic Implantable Infusion Pumps
You are subscribed to Medical Device Recalls for U.S. Food & Drug Administration (FDA). Information about the Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps Class I Recall has recently been updated, and is now available.
Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 25 Mar 2008 17:04:45 -0500 (CDT)
Subject: Voluntary Nationwide Recall of Honduran Cantaloupes grown by Agropecuaria Montelibano, San Lorenzo Valle, Honduras (March 24)
Voluntary Nationwide Recall of Honduran Cantaloupes grown by Agropecuaria Montelibano, San Lorenzo Valle, Honduras (March 24)
Tue, 25 Mar 2008 15:57:00 -0500
Central American Produce, Inc. of Pompano Beach, FL announces a voluntary recall of cantaloupes grown, packed and shipped by an independent third-party grower, Agropecuaria Montelibano of San Lorenzo Valle, Honduras.
Message: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 25 Mar 2008 20:03:09 -0500 (CDT)
Subject: FDA Warns Consumers Not to Use Blue Steel and Hero Products
FDA Warns Consumers Not to Use Blue Steel and Hero Products
Tue, 25 Mar 2008 18:55:00 -0500
These products are promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement.
Message: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 24 Mar 2008 14:30:51 -0500 (CDT)
Subject: MedWatch - December 2007 Monthly Safety Labeling Changes Posted on MedWatch Website
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The December 2007 posting includes 43 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.
The Summary Page provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/safety/2007/dec07_quickview.htm
The Detailed View Page identifies safety labeling sections and subsections revised along with a bref summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
http://www.fda.gov/medwatch/safety/2007/dec07.htm
In December 2007, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
Carbatrol (carbamazepine) Extended-Release Capsules
Equetro (carbamazepine) Extended-Release Capsules
Omniscan (gadodiamide) Injection for Intravenous Use
Tegretol (carbamazepine) USP, Chewable Tablets and Oral Suspension
Tegretol-XR (carbamazepine extended-release tablets)
Ambien CR (zolpidem tartrate extended-release) Tablets
AndroGel (testosterone gel) 1%
Dostinex (cabergoline) Tablets
Aredia (pamidronate disodium for injection)
Biaxin Filmtab (clarithromycin tablets, USP)
Biaxin XL Filmtab (clarithromycin extended-release tablets)
Biaxin Granules (clarithromycin for oral suspension, USP)
DepoDur (morphine sulfate extended-release liposome injection)
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil 0.01% (Body Oil)
Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules
Exjade (deferasirox) Tablets for Oral Suspension
Heparin Sodium Injection, USP
Heparin Sodium Injection, USP (porcine) 5,000 U/mL
Hepsera (adefovir dipivoxil) Tablets
Invega (paliperidone) Extended-Release Tablets
Levaquin (levofloxacin) Tablets and Oral Solution
Levaquin (levofloxacin) Injection, for Intravenous Use
Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use
Monodox (doxycycline monohydrate) Capsules
Sonata (zaleplon) Capsules
Message: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 25 Mar 2008 21:23:05 -0500 (CDT)
Subject: MedWatch - Blue Steel and Hero dietary supplements may cause severe lowering of blood pressure
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The U.S. Food and Drug Administration is advising consumers not to purchase or use "Blue Steel" or "Hero" products, marketed nationally as dietary supplements, because these products contain undeclared ingredients, which may dangerously affect a person’s blood pressure level. They are considered unapproved drugs and have not been proven to be safe or effective. These products are promoted and sold over the Internet for the treatment of erectile dysfunction [ED] and for sexual enhancement. They contain undeclared and unapproved substances similar in chemical structure to sildenafil, the active ingredient in an FDA-approved prescription drug for ED. The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels.
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#Hero
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