Recall Information from FDA http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Recalls/rss.xml en-us Fri, 20 Nov 2009 16:25:00 -0500 tina.gilliam@fda.hhs.gov Superior Foods Co., Grand Rapids, MI. is recalling Lemon Pepper Marinated Catfish because it may contain undeclared soy and FD&C Yellow #5. In addition, Superior Foods Co. is recalling Cajun Style Marinated Catfish because it may contain soy and milk that is not declared on the label. People who have an allergy or severe sensitivity to these run the risk of serious or life-threatening allergic reaction if they consume these products. Fri, 20 Nov 2009 16:25:00 -0500 http://www.fda.gov/Safety/Recalls/ucm191632.htm http://www.fda.gov/Safety/Recalls/ucm191632.htm Service Smoked Fish Corp. of Brooklyn, NY, is recalling specific “Use-By” dates and lot codes of Brooklyn’s BEST brand SMOKED NOVA SALMON because they have 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. Although healthy individuals may possibly suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Fri, 20 Nov 2009 08:27:00 -0500 http://www.fda.gov/Safety/Recalls/ucm191482.htm http://www.fda.gov/Safety/Recalls/ucm191482.htm – Fresh & Easy Neighborhood Market is voluntarily recalling some fresh&easy™ “Pumpkin Cheesecake Pies” (40 oz.) because they may contain undeclared pecans. Individuals who have allergies to pecans run the risk of serious or life-threatening allergic reaction if they consume these products. Fri, 20 Nov 2009 08:26:00 -0500 http://www.fda.gov/Safety/Recalls/ucm191479.htm http://www.fda.gov/Safety/Recalls/ucm191479.htm The Procter & Gamble Company (NYSE:PG) announced today it is voluntarily recalling three lots of its Vicks Sinex nasal spray in three countries: the United States, Germany and the United Kingdom. The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany. Thu, 19 Nov 2009 16:19:00 -0500 http://www.fda.gov/Safety/Recalls/ucm191416.htm http://www.fda.gov/Safety/Recalls/ucm191416.htm Nassau Candy Distributors of Hicksville, New York, is voluntarily recalling possibly unlabeled pegable snack tubs because they contain the following undeclared allergens; Tree Nuts {Almonds}, Soy and Milk and may contain the following undeclared allergens Peanuts, other Tree Nuts {brazil nuts, walnuts, filberts, hazelnuts, pecans, pistachios, macadamia nuts, cashews and coconut}. People who have an allergy to any of these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products... Thu, 19 Nov 2009 11:22:00 -0500 http://www.fda.gov/Safety/Recalls/ucm191309.htm http://www.fda.gov/Safety/Recalls/ucm191309.htm Snacks on Racks, Inc. of Parkville, Missouri is recalling products from their line of Gourmet Snacks Packs because they may contain undeclared milk, peanuts, tree nuts, soy, egg, sulfites or wheat. People who have an allergy or severe sensitivity to milk, peanuts, tree nuts, egg, sulfites, soy or wheat run the risk of serious or life-threatening allergic reaction if they consume these products. The complete list of recalled products are listed at the end of this press release. Tue, 17 Nov 2009 19:14:00 -0500 http://www.fda.gov/Safety/Recalls/ucm191010.htm http://www.fda.gov/Safety/Recalls/ucm191010.htm RockHard Laboratories announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplement sold under the name RockHard Weekend (RHW) specific to the following Lot Numbers: Blister Pack: T12 705 08 (exp: 10/11) / T12 705 09 (exp: 3/12, 8/12) 3ct Bottle: R417 0509 (exp: 09/12) 8ct Bottle: T237-0509 (exp: 06/12) RockHard Laboratories is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that voluntary lab analysis found that RHW, specific to the above lot numbers, contains sulfoaildenfil, an analogue of Sildenfil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making RockHard Weekend an unapproved drug. The active drug ingredient is not listed on the product label. Tue, 17 Nov 2009 15:59:00 -0500 http://www.fda.gov/Safety/Recalls/ucm191001.htm http://www.fda.gov/Safety/Recalls/ucm191001.htm – Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII) has announced a voluntary recall of all lots of the ViperSheathTM Sheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use. CSI initiated the nationwide recall on November 2, 2009. Tue, 17 Nov 2009 12:22:00 -0500 http://www.fda.gov/Safety/Recalls/ucm190879.htm http://www.fda.gov/Safety/Recalls/ucm190879.htm Cardiac Science Corporation [NASDAQ: CSCX] is initiating a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device’s periodic self-tests. Sat, 14 Nov 2009 13:04:00 -0500 http://www.fda.gov/Safety/Recalls/ucm190605.htm http://www.fda.gov/Safety/Recalls/ucm190605.htm IDS Sports announced today that it is conducting a voluntary nationwide recall of five of the company’s dietary supplement products sold under the following names: Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR. The Food And Drug Administration (FDA) has notified IDS Sports that the recalled products contain the following undeclared substances, which FDA considers to be steroids: “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione.” Fri, 13 Nov 2009 14:41:00 -0500 http://www.fda.gov/Safety/Recalls/ucm190446.htm http://www.fda.gov/Safety/Recalls/ucm190446.htm Today, ConAgra Foods, in cooperation with the U.S. Food and Drug Administration (FDA) is voluntarily recalling a limited number of 15 oz. tubs of Blue Bonnet Spread that were inadvertently mispackaged—the lid is for regular Blue Bonnet Spread and the tub portion describes the product as Blue Bonnet Light Spread. The product inside of the tub is regular Blue Bonnet Spread. As a result, the product tubs do not declare the allergen whey (milk), as an ingredient. Fri, 13 Nov 2009 14:38:00 -0500 http://www.fda.gov/Safety/Recalls/ucm190507.htm http://www.fda.gov/Safety/Recalls/ucm190507.htm Herbal Products, Inc. has been informed by the Food and Drug Administration (FDA) that Pai You Guo, a weight loss dietary supplement, sold and marketed by the firm contains undeclared drug ingredients. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States. Fri, 13 Nov 2009 12:48:00 -0500 http://www.fda.gov/Safety/Recalls/ucm190403.htm http://www.fda.gov/Safety/Recalls/ucm190403.htm Reports of loss of device height, which may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for surgery to modify the implanted device. Thu, 12 Nov 2009 16:08:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190330.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190330.htm Product, used during cardiopulmonary bypass procedures, may spontaneously rupture during surgery. Mon, 09 Nov 2009 22:37:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189650.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189650.htm Hospira, Inc. (NYSE: HSP), a global specialty pharmaceutical and medication delivery company, is voluntarily recalling 85 lots of Liposyn™ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80 because some of the containers may contain particulate matter. The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process. Mon, 09 Nov 2009 13:34:00 -0500 http://www.fda.gov/Safety/Recalls/ucm189564.htm http://www.fda.gov/Safety/Recalls/ucm189564.htm Jelly Belly Candy Company is recalling 7.5-ounce cylinder-style packages of 49 Flavors Jelly Belly jelly beans because the package is incorrectly labeled. The mislabeled packages failed to list peanut butter and peanut flour in the ingredient statement... Fri, 06 Nov 2009 10:50:00 -0500 http://www.fda.gov/Safety/Recalls/ucm189402.htm http://www.fda.gov/Safety/Recalls/ucm189402.htm The U.S. Food and Drug Administration is issuing this health alert to warn consumers not to use Pig Ears and Beef Hooves pet treats manufactured by Pet Carousel because the products may be contaminated with Salmonella. The products were distributed nationwide in both bulk and retail packaging for sale in pet food and retail chain stores. Pet Carousel is based in Sanger, Calif. Thu, 05 Nov 2009 20:59:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189400.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189400.htm PetSmart (NASDAQ: PETM) is voluntarily recalling two Dentley’s Beef Hoof products for potential salmonella contamination. The products were manufactured by Pet Carousel, Inc. in Sanger, Calif. Thu, 05 Nov 2009 14:51:00 -0500 http://www.fda.gov/Safety/Recalls/ucm189296.htm http://www.fda.gov/Safety/Recalls/ucm189296.htm Kits recalled because the pediatric tracheal tubes were manufactured with an internal diameter smaller than indicated on the label. Wed, 04 Nov 2009 10:02:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188981.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188981.htm Charleston Cookie Company of Charleston, SC is recalling packages of Almond Cookies which were sold as a component of the Dean and Deluca "Americana" cookie tin because the cookies contain undeclared butter (milk). Wed, 04 Nov 2009 09:26:00 -0500 http://www.fda.gov/Safety/Recalls/ucm188971.htm http://www.fda.gov/Safety/Recalls/ucm188971.htm