Health and Beauty: 12/02/08

What's New at CBER Update

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Biological Product Shortage - Digoxin Immune Fab (Ovine)
Posted: 2/12/2008

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CDER New 2/11/2008

Center for Drug Evaluation and Research, U.S. Food and Drug Administration

February 11, 2008

FDA announces that Baxter Healthcare Corp. has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension.
National Drug Code Directory Download (updated)
National Drug Code Directory Search (updated)
Office of Generic Drugs: January First-Time Generic Drug Approvals
Paragraph IV Patent Certifications (updated)

CDER Home Page | Contact CDER | FDA Home Page | HHS Home Page

U.S. Food and Drug Administration
Center for Drug Evaluation and Research
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Recent Device Approvals: xTAG[TM] Respiratory Viral Panel (RVP)

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Recent Device Approvals: Endeavor® Zotarolimus-Eluting Coronary Stent

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Nick and Katie's, Inc. Issues Allergy Alert on Undeclared Milk, Soy, and Wheat in Crab Stuffed Mushrooms, Crayfish, Stuffed Portabella Mushroom, Stuffed Bell Pepper, Stuffed Crab, Mediterranean Stuffed Artichoke, Stuffed Italian Artichoke, and Artichoke Balls (Feb. 7)

Nick and Katie's, Inc. Issues Allergy Alert on Undeclared Milk, Soy, and Wheat in Crab Stuffed Mushrooms, Crayfish, Stuffed Portabella Mushroom, Stuffed Bell Pepper, Stuffed Crab, Mediterranean Stuffed Artichoke, Stuffed Italian Artichoke, and Artichoke Balls (Feb. 7)
Tue, 12 Feb 2008 05:14:00 -0600

These products are being recalled because they contain milk, soy, and wheat that was distributed in packaging that did not reveal the presence of milk, soy, and wheat. People who have an allergy or severe sensitivity to milk, soy, or wheat run the risk of a serious or life-threatening allergic reaction if they consume these products.

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Annie's Naturals Issues Voluntary Nationwide Allergy Alert on Undeclared Soy in 8 fl oz. All-Natural Shiitake and Sesame Vinaigrette (Feb. 11)

Annie's Naturals Issues Voluntary Nationwide Allergy Alert on Undeclared Soy in 8 fl oz. All-Natural Shiitake and Sesame Vinaigrette (Feb. 11)
Tue, 12 Feb 2008 04:57:00 -0600

Annie's Naturals is voluntarily recalling 686 cases of 8 fl oz. bottles of all-natural Shiitake and Sesame Vinaigrette. The product could be mislabeled and may contain soy sauce (contains soy and wheat) and sesame that were not declared on the ingredient statement. People who have an allergy or severe sensitivity to soy run the risk of serious allergic reaction if they consume this product.

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Onion Crock of Michigan recalls Old Fashion Potato, Minestrone soups due to Undeclared Allergens (Wheat and Soy)(Feb. 6)

Onion Crock of Michigan recalls Old Fashion Potato, Minestrone soups due to Undeclared Allergens (Wheat and Soy)(Feb. 6)
Tue, 12 Feb 2008 04:48:00 -0600

Old Fashion Potato may be packed in one pound frozen pouches (upc # 643640010772) or in four or eight pound pouches (upc codes # 643640001053) with any Best if used by dates of 7/21/09 or earlier. Minestrone packaged in one pound frozen pouches (upc # 64364001111) or in four or eight pound pouches (upc codes # 643640001138) or with any Best if Used by dates of 7/08/09 or earlier.

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CDRH New Update

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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

Date: February 12, 2008

The following new items were added to the CDRH web pages on February 11, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Consumer Information on: xTAG™ Respiratory Viral Panel (RVP) - K063765

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Thankful For You

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Family Skiing Holidays in France
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Thankful For You
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