FDA proposes draft menu and vending machine labeling requirements, invites public to comment on proposals

The U.S. Food and Drug Administration today issued two proposed regulations regarding calorie labeling on menus and menu boards in chain restaurants, retail food establishments, and vending machines. The FDA invites input on the proposed regulations by visiting http://www.regulations.gov. (SY)

Centurion Medical Products Initiates Voluntary Recall of Customized Convenience Kits (including select Central Venous Catheter, PICC Insertion, and VAD Trays) that contain American Regent’s Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials

Centurion Medical Products Corporation, of Williamston, Michigan, has initiated a recall of certain customized convenience kits that contain Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials manufactured by Luitpold Pharmaceuticals, Inc., and distributed by American Regent, Inc. This action is in response to American Regent’s recall of three lots of vials because some may contain visible particulates.

Sassy Cow Creamery, LLC Issues Allergy Alert On Peanut Oil In Butter Pecan Ice Cream And Egg And Soy In Blueberry Cheesecake Ice Cream

Sassy Cow Creamery, LLC of Columbus, WI is recalling Blueberry Cheesecake and Butter Pecan Ice Cream because it may contain undeclared peanuts or egg and soy. People who have an allergy or severe sensitivity to egg, soy, or peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.
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Frankly Fresh Inc. Voluntarily Recalls Seafood Salad Products Because Of Possible Health Risk

Frankly Fresh, Inc. of Carson, CA. Is voluntarily recalling its seafood line of products, because it has
the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious
and sometimes fatal infections in young children, frail or elderly people, and others with weakened
immune systems.
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Thomas Produce Recalls Jalapeno Peppers Because of Possible Health Risk

Thomas Produce of Boca Raton, FL, is recalling 320 boxes of Jalapeno Peppers because they have the
potential to be contaminated with Salmonella, an organism which can cause serious and sometimes
fatal infections in young children, frail or elderly people, and others with weakened immune systems. The recalled Jalapeno Peppers were sold to distributors in Florida, New York, North Carolina, New
Jersey, Minnesota, and Pennsylvania from 2/15/2011 to 2/18/2011.

FDA Issues Statement on Makena

On February 3, 2011, the Food and Drug Administration approved the drug Makena (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. KV Pharmaceuticals, the drug’s owner, received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug’s effectiveness. It also obtained seven years of exclusivity under the Orphan Drug Act, obtained approval under FDA’s accelerated approval program, and received expedited review.