U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 23 Jun 2008 06:00:46 -0500 (CDT)
Subject: CDRH New Update

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

Date: June 23, 2008

The following new items were added to the CDRH web pages on June 20, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Office of Device Evaluation (ODE) Fiscal Year 2006 and Fiscal Year 2007 Annual Report

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 23 Jun 2008 17:03:36 -0500 (CDT)
Subject: Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23)

Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23)
Mon, 23 Jun 2008 16:23:00 -0500

Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 23 Jun 2008 12:37:28 -0500 (CDT)
Subject: FDA MedWatch - February 2008 Drug Safety Labeling Changes for 47 drugs now available on web

The February 2008 posting includes 47 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/2008/feb08_quickview.htm

The Detailed View Page identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda.gov/medwatch/SAFETY/2008/feb08.htm

In February 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets

Cleocin Sterile Solution (clindamycin injection)

Cleocin Phosphate (clindamycin injection in 5% dextrose) IV Sterile Solution

Duragesic (fentanyl) Transdermal System

Emsam (selegiline transdermal system) Patches

Fentora (fentanyl buccal tablet)

Lincocin (lincomycin) Injection

Asmanex Twisthaler (mometasone furoate inhalation powder)

Abilify (aripiprazole) Tablets and Oral Solution

Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets

Abilify (aripiprazole) Injection for Intramuscular Use Only

Avastin (bevacizumab) for Intravenous Use

Claforan Sterile (cefotaxime sodium for injection, USP) and Injection (cefotaxime sodium injection, USP)

Cortenema (hydrocortisone retention enema)

Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets

Eryc (erythromycin delayed-release capsules, USP)

Erythrocin Lactobinate (erythromycin lactobionate) Injection, Powder, Lyophilized, For Solution

Geocillin (carbenicillin indanyl sodium) Tablets

Halcion (triazolam tablets)

Janumet (sitagliptin/metformin HCl) Tablets

Letairis (ambrisentan) Tablets

Premarin Intravenous (conjugated estrogens, USP) for injection

Remodulin (treprostinil sodium) Injection

Restoril (temazepam) Capsules

Reyataz (atazanavir sulfate) Capsules 

Sensipar (cinacalcet) Tablets

Ultram ER (tramadol HCl) Extended-Release Tablets

Vibramycin Calcium (doxycycline calcium oral suspension, USP) Oral Suspension Syrup

Vibramycin Hyclate (doxycycline hyclate capsules, USP) Capsules

Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension

Vibra-Tabs (doxycycline hyclate tablets, USP) Film Coated Tablets

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