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, 28 Apr 2008 06:21:27 -0500 (CDT)
Subject: CDRH New Update

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

Date: April 28, 2008

The following new items were added to the CDRH web pages on April 25, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

FDA Clears Glove Made from New Type of Latex

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Apr 2008 10:08:00 -0500 (CDT)
Subject: Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as precaution (April 25)

Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as precaution (April 25)
Mon, 28 Apr 2008 09:50:00 -0500

Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Apr 2008 10:19:25 -0500 (CDT)
Subject: Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern (Red Only) Stoneware Dinnerware Product Lines (April 28)

Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern (Red Only) Stoneware Dinnerware Product Lines (April 28)
Mon, 28 Apr 2008 09:50:00 -0500

Lifetime Brands, Inc., of Garden City, New York, today announced that, as a result of its internal compliance and independent product testing programs, it recently became aware that certain Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern stoneware dinnerware products may exceed the Food and Drug Administration's guidance levels for lead and/or cadmium.

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Apr 2008 14:44:16 -0500 (CDT)
Subject: FDA MedWatch- Digitek (digoxin tablets)-Class I Recall Because Tablets May Contain Twice The Approved Level Of Active Ingredient

Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:

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

 

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