Food and Drug Administration--Recalls

FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes (November 5) (Wed, 05 Nov 2008 23:31:00 GMT) The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

General Mills Issues Voluntary Class One Recall Involving One Day's Production of Progresso Hearty Tomato Soup (October 31) (Mon, 03 Nov 2008 17:32:00 GMT) General Mills is voluntarily recalling a single day's production of Progresso Hearty Tomato soup because of a product labeling issue. Product produced on this date may have been mislabeled, and may contain allergens not listed on the ingredient label, specifically egg, milk, and soy.

Everlasting Distributors Inc. Issues a Nationwide Recall of Fresh and Crispy Jacobina Biscuits Because of Possible Health Risks (October 29) (Fri, 31 Oct 2008 20:33:00 GMT) Everlasting Distributors Inc., Bayonne NJ is initiating a nationwide recall of all their 3.88oz (110gm) packages of Fresh and Crispy Jacobina Biscuits because it may be contaminated with Melamine.

Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination (Mon, 27 Oct 2008 23:46:00 GMT) Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella.

Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24) (Sun, 26 Oct 2008 10:26:00 GMT) Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death.

Nonna's Real Italiana Cuccine Issues an Allergy Alert on Undeclared Milk, Soy, and Wheat in Stuffed Artichokes (October 22) (Wed, 22 Oct 2008 21:57:00 GMT) This product is distributed through retailers in the Greater New Orleans area including the Northshore from October 8, 2008 to October 17, 2008. The product is individually wrapped in clear plastic wrap bearing the label: "STUFFED ARTICHOKE, Net Wt. 15 oz., NONNA'S REAL ITALIANA CUCCINE".

Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry and David Moose Munch Confection, Milk Chocolate Gingerbread (October 22) (Wed, 22 Oct 2008 20:31:00 GMT) Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry and David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product.

The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk (October 20) (Mon, 20 Oct 2008 23:08:00 GMT) The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall.

Lotte USA, Inc. Initiates Nationwide Recall of Koala's March Creme filled Cookies (Sat, 18 Oct 2008 10:00:00 GMT) Lotte USA, Inc., Battle Creek, MI initiated a recall of all Koalas' March Cookies on September 29, 2008 because they were produced in China and they may be contaminated with melamine. The products are packaged in a plastic overwrap.

ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15) (Wed, 15 Oct 2008 19:19:00 GMT) ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side.

JFC International, Inc. Issues Allergy Alert on Undeclared Sulfite in "Kyosai Sengiri Daikon" Dried Radish (October 10) (Tue, 14 Oct 2008 18:36:00 GMT) JFC International, Inc. is recalling all products of Kyosai Sengiri Daikon (40/3.50z) due to the present of undeclared sulfite. People who have an allergy or severe sensitivity to sulfite run the risk of life-threatening allergic reaction if they consume this product.

Barry Callebaut USA LLC Issues Allergen Alert on Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips (October 10) (Tue, 14 Oct 2008 13:36:00 GMT) Barry Callebaut USA LLC is conducting a voluntary recall on its product sold by Kroger Stores under the brand "Kroger Value Semi Sweet Chocolate Chips", 12 oz., UPC Code is 11110–86603 and "sell by" date May 30, 2010, as the product may contain undeclared milk protein. The "sell by" date is found printed in black on the end of the bag. People with allergies or severe sensitivity to milk protein may be at risk of serious or life-threatening allergic reaction if they consume this product.

HUA XIA Food Trade USA, Inc. Recalls YILI Brand Sour Milk Drink and YILI Brand Pure Milk Drink, Because of Possible Health Risk (October 10) (Tue, 14 Oct 2008 09:44:00 GMT) HUA XIA Food Trade USA, Inc. of Flushing, NY, is recalling YILI Brand Sour Milk Drink packaged in 250ml flexible paperboard boxes (all codes and all lots are affected) and YILI Brand Pure Milk Drink packaged in 250ml flexible paperboard boxes (all codes and all lots are affected) because it may be contaminated with melamine.

Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates (October 9) (Fri, 10 Oct 2008 12:40:00 GMT) The recalled product was distributed in the following states and cities: Texas, California, Louisiana, North Carolina, South Carolina, Virginia, Tennessee; Southaven, Mississippi; Billings, Montana; Sparks, Nevada; and Madison Heights, Michigan. An investigation determined 29 boxes of this candy may have been purchased by consumers, and up to another 188 boxes may have reached retail store locations. All the retail stores have been contacted to have the suspected product removed from the shelves.