Food and Drug Administration -- Recalls/Safety Alerts

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LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc)
Today, September 16, 2009
Class I recall due to failure or delay in delivery of therapy.


FDA Requires Boxed Warning for Promethazine Hydrochloride Injection
Today, September 16, 2009
The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA’s authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative and to treat nausea and vomiting.


AFC Trading & Wholesale Recalls AFC Beancurd Sheets and Sticks for Undeclared Sulfites
Yesterday, September 15, 2009
AFC Trading & Wholesale, Inc., of Los Angeles, CA, recalls AFC Frozen Beancurd Sheets (8oz. & 16oz.) and AFC Frozen Beancurd Sticks (8oz.) because of it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products. No illnesses have been reported to date.


Shil La Dang Recalls Gimbob Fish Cake and Modeum, Combination, Sultok and Bean Seolki Rice Cakes Because Of Undeclared Allergens
Sunday, September 13, 2009
Shining Marble Corporation dba Shil La Dang, Gardena, CA, is recalling its Gimbob (fish cake sushi), Modeum rice cake, combination rice cake, Sultok rice cake, and Bean Seolki rice cake. The Gimbob Fish Cake does not declare tempura fish, wheat, or soybean as an ingredient. The Modeum, Combination, Sultok, and Bean Seolki rice cakes do not declare chestnuts as an ingredient.


Muranaka Farm, Inc. Voluntarily Recalls 60 Count Bunched Parsley Because of Possible Salmonella
Saturday, September 12, 2009
Muranaka Farm, Inc. of Moorpark, CA is recalling 1005 cases of 60 count bunched Parsley, because it has 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.


Kilwin's Quality Confections, Inc. Conducted Nationwide Recall of Chocolate-Covered Peanuts Because of Possible Health Risk
Friday, September 11, 2009
Kilwin’s Quality Confections, Inc. of Petoskey, MI, is recalling all of our 7 ounce packages of chocolate-covered peanuts, and bulk chocolate-covered peanuts, sold in our retail stores, which were sold prior to April 1, 2009, 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.


Arbonne International, LLC Announces Voluntary Recall of One Lot of Seasource Detox Spa® Foaming Sea Salt Scrub
Friday, September 11, 2009
Arbonne International, LLC (“Arbonne”) has voluntarily recalled one lot of its Seasource Detox Spa® Foaming Sea Salt Scrub. The recalled products were manufactured by a third party and distributed nationwide through Arbonne Independent Consultants.


Smiths Medical Issues Urgent Device Recall Of Portex® Pediatric-Sized Tracheal Tubes
Friday, September 11, 2009
FOR IMMEDIATE RELEASE - ST. PAUL, Minn. - 10 September 2009 - Smiths Medical announced that it is initiating a nationwide voluntary recall ofPortex® Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm) manufactured before September 2009.


Chulada, Inc. Announces Recall of Saladitos c/ Chile (Salted Plum w/ Chile Powder)
Thursday, September 10, 2009
Chulada, Inc. of Burbank, CA is recalling all Chulada Brand Saladitos c/ Chile (Salted Plum w/ Chile Powder) due to elevated levels of lead. Chulada, Inc. learned on 6/10/09 from the California Department of Public Health (CDPH), that Saladitos c/ Chile (Salted Plum w/ Chile Powder) contains high levels of lead that could cause health problems to consumers, particularly infants, small children, and pregnant women.


CONMED Corporation Announces Voluntary Recall of Certain Powered Surgical Instrument Products
Wednesday, September 09, 2009
CONMED Corporation’s (Nasdaq: CNMD) CONMED Linvatec unit announced today a voluntary recall for certain model numbers of the PRO5 & PRO6 series battery handpieces manufactured prior to May 31, 2008, and certain lots of the MC5057 Universal Cable manufactured prior to December 1, 2006 used with certain of CONMED Linvatec’s electric powered handpieces.


Penumbra Neuron 5F Select Catheter
Wednesday, September 09, 2009
Class 1 recall due to defect which may result in brain blood clot and blood vessel puncture.


PREMIER ORGANICS Issues Nation Wide Recall For ARTISANA RAW TAHINI Because of Possible Health Risk
Tuesday, September 08, 2009
Premier Organics of Berkeley, CA is recalling 840 Cases of Artisana Raw Tahini of Lot 90811, in 16oz glass jars because it has the potential to be contaminated with Salmonella, an organism which can cause serious infections. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections, endocarditis and arthritis.


Georgia Agriculture Department Finds Listeria in Sample of Eggo Buttermilk Waffles at Atlanta Plant
Thursday, September 03, 2009
A laboratory test by the Georgia Department of Agriculture (GDA) found Listeria monocytogenes in a sample of Kellogg’s Buttermilk Eggo Waffles manufactured at an Atlanta plant. The sample was taken as part of a routine inspection by GDA of the Kellogg’s plant at 5601 Bucknell Dr. SW, Atlanta. This product was not shipped into the marketplace.


OCEAN MIST FARMS Announces Precautionary, Voluntary Recall of 1,746 Cases of Iceless Green Onions
Tuesday, September 01, 2009
CASTROVILLE, CA – August 28, 2009 – Although no Ocean Mist Farms’ product has been identified, the company immediately began a precautionary, voluntary recall of 1,746 cases of iceless green onions. This decision follows confirmation from federal regulators of a positive test for salmonella on iceless green onions supplied by Circle Produce to several shippers, including Ocean Mist Farms.


TEXAS COFFEE Company Recalls Red Pepper Because of Possible Health Risk
Tuesday, September 01, 2009
The Texas Coffee Company, Inc. of Beaumont, TX, is recalling its 3 ounce and 8 oz. packages of Texjoy red pepper 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.


Voluntary Product Recall: Steinbeck Country Green Onions
Tuesday, September 01, 2009
As a result of routine testing, the USDA has found a positive result for salmonella on iceless green onions shipped by Steinbeck Country Produce of Salinas, CA. The onions were farmed and packed by a grower in Mexicali, Mexico, near the California border.


PETRI BAKING Products Issues Allergy Alert On One Code Of Stop & Shop Molasses Cookies
Tuesday, September 01, 2009
Petri Baking Products, Inc. is issuing a voluntary recall on one code of Stop & Shop Home Town Bakery Old Fashioned Molasses Cookies, Net Wt. 8.9 oz. The affected packages actually contain Peanut Butter Cookies that have peanut butter and milk which are undeclared allergens. People who have an allergy to peanuts and/or milk run the risk of serious or life-threatening allergic reaction if they consume this product.


Undeclared Sulfites in "Island Snacks Natures Mix"
Saturday, August 29, 2009
New York State Agriculture Commissioner Patrick Hooker today alerted consumers that Snack King Foods, Inc., located at 675 Pullman Avenue, Rochester, New York is recalling "Island Snacks Natures Mix" due to the presence of undeclared sulfites. People who have severe sensitivity to sulfites may run the risk of serious or life-threatening reactions if they consume this product.


Melon Acres Announced the Recall of Cantaloupes Distributed Through Farm-Wey Produce of Lakeland FL Due to Potential Health Concerns
Saturday, August 29, 2009
Melon Acres announced the recall of cantaloupes distributed through Farm-Wey Produce of Lakeland, FL due to potential health concerns. The cantaloupes were shipped August 13th and 14th and were identified as 41 MG 10, Bin Numbers 4753-4980.


Voluntary Prodcut Recall: Chef Pierre® Gourmet Lemon Meringue Pie, Day Code 9159 Only
Saturday, August 29, 2009
Chef Pierre® is voluntarily recalling a partial production run of the following foodservice product as a precautionary measure as the product may contain milk, an undeclared allergen, posing a potential serious and life-threatening health risk to milk-allergic individuals. This recall affects 4,380 cases of Chef Pierre Gourmet Lemon Meringue Pie labeled product that actually contained chocolate meringue pie.


Source: www.fda.gov