From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 10 Jun 2008 05:43:51 -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: June 10, 2008 |
The following new items were added to the CDRH web pages on June 9, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Medical Device Safety, Tips & Articles: How Human Factors Lead to Medical Device Adverse Events |  | |
| Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. | |  |
| Summary Information for: Talent™ Thoracic Stent Graft System | |
Updates: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 10 Jun 2008 09:04:43 -0500 (CDT)
Subject: ETHEX Corporation Voluntarily Recalls a Single Lot of Morphine Sulfate 60 mg Extended Release Tablets Due to the Potential for Oversized Tablets (June 9)
ETHEX Corporation Voluntarily Recalls a Single Lot of Morphine Sulfate 60 mg Extended Release Tablets Due to the Potential for Oversized Tablets (June 9)
Tue, 10 Jun 2008 08:10:00 -0500
ETHEX Corporation announced today that it has voluntarily recalled a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. No other dosage strength, nor any other lot of the 60 mg strength is affected by this recall.
Updates: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 10 Jun 2008 09:07:24 -0500 (CDT)
Subject: Lake Country Lamb Feed Voluntary Recall (June 6)
Lake Country Lamb Feed Voluntary Recall (June 6)
Tue, 10 Jun 2008 08:28:00 -0500
The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper.
Updates: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 10 Jun 2008 09:07:54 -0500 (CDT)
Subject: Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6)
Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6)
Tue, 10 Jun 2008 09:01:00 -0500
Leiner Health Products Inc. announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products.
Updates: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 10 Jun 2008 13:04:04 -0500 (CDT)
Subject: Red Tomato Warning Expanded Nationwide
Red Tomato Warning Expanded Nationwide
Tue, 10 Jun 2008 12:38:00 -0500
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these tomatoes.
Updates: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 10 Jun 2008 16:08:54 -0500 (CDT)
Subject: FDA 101: How to Use the Consumer Complaint System and MedWatch
FDA 101: How to Use the Consumer Complaint System and MedWatch
Tue, 10 Jun 2008 15:57:00 -0500
When you have a problem with a food, drug, or other FDA-regulated product, FDA wants to hear from you. Here's how to report problems using two of FDA's main reporting systems.
Updates: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 10 Jun 2008 16:09:03 -0500 (CDT)
Subject: Your Guide to Reporting Problems to FDA
Your Guide to Reporting Problems to FDA
Tue, 10 Jun 2008 15:57:00 -0500
This guide provides tips and a quick-reference chart to help you report a problem to FDA.
Updates: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 10 Jun 2008 13:30:05 -0500 (CDT)
Subject: FDA MedWatch - Morphine Sulfate 60 mg Extended Release Tablets - Recall of a Single Lot Due to a Report of a Tablet With Twice the Appropriate Thickness
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ETHEX Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual. If consumers have any questions about the recall, they should call their physician, pharmacist, or other health care provider.
Read the MedWatch 2008 safety summary, including a link to the firm's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Morphine
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