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NEWS: U.S. Food and Drug Administration (FDA)

Class I Medical Device Recall: Ikaria Holdings, INOMAX DS Drug Delivery System

FDA: Medical Device Information For Consumers - Sun, 08/22/2010 - 23:00
Reason for Recall: A component within the pressure switch, which monitors when the drug supply should be replaced, may tear. Risks to the patient may include interruption of drug flow due to an empty cylinder, and/or the time taken to switch to a...
Categories: NEWS: U.S. Food and Drug Administration (FDA)

Lubersk i Inc., Initiates Voluntary Recall of Large Fresh Shell Eggs Because of Possible Health Risk

FDA: Recalls - Sat, 08/21/2010 - 14:00
The following statement was released by officials of Luberski Inc. regarding the voluntary recall of shell eggs supplied from Wright County Egg of Galt, Iowa. Luberski Inc. is voluntarily recalling specific Julian dates of shell eggs produced by Wright County Egg of Galt, Iowa because they have the potential to be contaminated with Salmonella.
Categories: NEWS: U.S. Food and Drug Administration (FDA)

Milton's Baking Voluntarily Recalls 24 oz. Multi-Grain Bread in Three States For Undeclared Milk in Some Loaves

FDA: Recalls - Fri, 08/20/2010 - 17:07
Milton's Baking Company is voluntarily recalling Milton's Multi-Grain Bread which was distributed to locations in Northern and Central California, Arizona and Nevada. The company took the precautionary step because the loaves contain milk, an undeclared allergen, which may pose a potential serious and life-threatening health risk to milk-allergic individuals.
Categories: NEWS: U.S. Food and Drug Administration (FDA)

GloryBee Foods Recalls Whole Raw Pistachio and Whole Raw Pistachio Kernels Because of Possible Health Risk

FDA: Recalls - Fri, 08/20/2010 - 16:07
GloryBee Foods, Inc., of Eugene, Oregon is voluntarily recalling Aunt Patty's brand 5 pound bags of Whole Raw Pistachios and 25 lb. boxes of Specialty Commodities brand Whole Raw Pistachios Kernels, 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.
Categories: NEWS: U.S. Food and Drug Administration (FDA)

Austinuts Wholesale, Inc. Announces Voluntary Recall of Pistachio Kernel Products

FDA: Recalls - Fri, 08/20/2010 - 15:15
AustiNuts Wholesale, Inc. is issuing this voluntary recall of pistachio kernel products due to a recall that was issued by it's supplier California Delights, Inc. California Delights, Inc issued a recall for two shipments of pistachio kernels received by AustiNuts Wholesale, Inc. in July 2010 due to the possibility of contamination with Salmonella.
Categories: NEWS: U.S. Food and Drug Administration (FDA)

Salmonella in Alfalfa Sprouts

FDA: Recalls - Fri, 08/20/2010 - 14:53
New York State Agriculture Commissioner Patrick Hooker today alerted consumers that Snow White Food Products Inc., located in 621 Bergen Street in Brooklyn, New York, is recalling certain packages of "Alfalfa Sprouts" due to the presence of Salmonella. The recalled "Alfalfa Sprouts" is packaged in a 3.5 ounce plastic clamshell container which is uncoded. It has a UPC code of 0-46421-11236-6. The product was distributed in New York State.
Categories: NEWS: U.S. Food and Drug Administration (FDA)

Urgent Nationwide Frozen Mamey Fruit Products Recall

FDA: Press Releases - Fri, 08/20/2010 - 13:29
An investigation by the CDC and state partners showed an epidemiologic link between an ongoing outbreak of Salmonella Typhi and frozen mamey fruit products sold under the La Nuestra brand by Montalvan Sales Inc. Ontario, Calif, and under the Goya brand by Goya Foods Inc. Secaucus, New Jersey.
Categories: NEWS: U.S. Food and Drug Administration (FDA)

Hillandale Farms of Iowa Conducts Nationwide Voluntary Recall of Shell Eggs Because of Possible Health Risk

FDA: Recalls - Fri, 08/20/2010 - 13:10
Hillandale Farms of Iowa is voluntarily recalling shell eggs because they have the potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Categories: NEWS: U.S. Food and Drug Administration (FDA)

Montalvan’s Sales, Inc. Recalls “La Nuestra” Brand Frozen Mamey Because of Potential Health Risk

FDA: Recalls - Fri, 08/20/2010 - 07:50
As a precautionary measure, Montalvan’s Sales, Inc. of Ontario, CA has voluntarily recalled “La Nuestra” brand frozen mamey pulp due to a potential health risk from Salmonella Typhi. Typhoid fever is a life-threatening illness caused by the bacterium Salmonella Typhi.
Categories: NEWS: U.S. Food and Drug Administration (FDA)

Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk

FDA: Medical Watch - Thu, 08/19/2010 - 23:00
FDA evaluating clinical trial data that suggest patients taking drug may be at an increased risk for cardiovascular events compared to those taking carbidopa/levodopa
Categories: NEWS: U.S. Food and Drug Administration (FDA)

Urgent Nationwide Egg Recall

FDA: Press Releases - Thu, 08/19/2010 - 18:46
The current recall of eggs in their shells, or “shell eggs,” is part of an ongoing and intensive investigation by local, state, and federal officials into the cause of recent cases of Salmonella Enteritidis.
Categories: NEWS: U.S. Food and Drug Administration (FDA)

COUNTRY Eggs, Inc. Initiates Voluntary Recall of Large AA Loose 15 dozen Fresh Shell Eggs Because of Possible Health Risk

FDA: Recalls - Thu, 08/19/2010 - 15:18
The following statement was released by officials of Country Eggs, Inc. regarding the voluntary recall of shell eggs supplied from Wright County Egg of Galt, Iowa. Country Eggs, Inc. is voluntary recalling specific Julian dates of shell eggs produced by Wright County Egg of Galt, Iowa because they have the potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems...
Categories: NEWS: U.S. Food and Drug Administration (FDA)

U.S. Marshals seize food from rodent-infested Ga. warehouse

FDA: Press Releases - Thu, 08/19/2010 - 13:26
U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, today seized packaged food products from a rodent-infested warehouse in Athens, Ga. A variety of products, including crackers, cookies and potato chips, were intended for sale to jails and prisons throughout the southeastern United States.
Categories: NEWS: U.S. Food and Drug Administration (FDA)

Wright County Egg Expands Nationwide Voluntary Recall of Shell Eggs Because of Possible Health Risk

FDA: Recalls - Thu, 08/19/2010 - 06:59
Wright County Egg of Galt, Iowa is expanding its voluntary recall (original recall date: August 13, 2010) of specific Julian dates of shell eggs produced by their farms because they have the potential to be contaminated with Salmonella. Salmonella is 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, 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 or arthritis.
Categories: NEWS: U.S. Food and Drug Administration (FDA)

NuCal Foods Conducts Recall of Shell Eggs Supplied from Wright County Egg Because of Possible Health Risk

FDA: Recalls - Thu, 08/19/2010 - 06:59
NuCal Foods is voluntarily recalling specific Julian dates of shell eggs produced by Wright County Egg and packaged by NuCal Foods because they have the potential to be contaminated with Salmonella. Salmonella is 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, 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 or arthritis.
Categories: NEWS: U.S. Food and Drug Administration (FDA)

J & H Besta Expands Nationwide Recall of Slim- 30 Herb Supplement to Include Lot 6032101 Found to Contain an Undeclared Drug Ingredient

FDA: Recalls - Thu, 08/19/2010 - 06:57
J & H Besta Corp. of Hicksville, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analysis of Slim-30 Herb Supplement Lot 6032101 distributed by the company was found to contain undeclared Desmethyl Sibutramine, similar in structure to Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved Slim-30 Herbal Supplement, therefore the safety and effectiveness of the product is unknown.
Categories: NEWS: U.S. Food and Drug Administration (FDA)

Moonstruck Chocolate Co. Issues Nationwide Allergy Alert on Undeclared Peanut-Butter Filling in Their 4 Piece Cream Cone Chocolate Truffle Collection and 12 Piece Chocolate Malted (or Malt) Cream Cone Chocolate Truffles

FDA: Recalls - Wed, 08/18/2010 - 20:18
Moonstruck Chocolate Co. of Portland, Oregon is voluntarily recalling their 4 piece Cream Cone Chocolate Truffle Collection and the 12 piece Chocolate Malted (or Malt) Cream Cone Chocolate Truffles, because they may contain undeclared peanut butter. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
Categories: NEWS: U.S. Food and Drug Administration (FDA)

Glow Industries, Inc. Issues Nationwide Recall of Mr. Magic Male Enhancer from Don Wands Amended

FDA: Recalls - Wed, 08/18/2010 - 15:41
Glow Industries, Inc., Perrysburg, OH, announced today that it is initiating a voluntary nationwide recall of the company's product sold under the name of Mr. Magic Male Enhancer from Don Wands. Glow Industries, Inc. is conducting this voluntary recall after being informed by the Food and Drug Administration (FDA) that lab analysis has found the Mr. Magic Male Enhancer from Don Wands capsules to contain Hydroxythiohomosildenafil and Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making Mr. Magic Male Enhancer an unapproved new drug. These active ingredients are not listed on the product label. Product manufactured containing lot numbers 9041401, 251209 and 8121904 are included in this recall...
Categories: NEWS: U.S. Food and Drug Administration (FDA)

Undeclared Sulfites in "Golden Bridge" Dried Dates

FDA: Recalls - Wed, 08/18/2010 - 14:40
New York State Agriculture Commissioner Patrick Hooker today alerted consumers that Sunny Lake Trading Inc, located at 651A Lexington Ave, Brooklyn, New York is recalling "Golden Bridge" dried dates 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.
Categories: NEWS: U.S. Food and Drug Administration (FDA)

Elie Baking Corp issues Allergy Alert on Undeclared Soy in Food City brand Low-Carb Tortilla White and Whole Wheat 10 count

FDA: Recalls - Wed, 08/18/2010 - 12:01
Elie Baking Corp. dba Near East Baking Corporation, 204 N Montello St,, Brockton, Massachusetts is recalling the following: Food City brand, Low Carb Tortilla White, 13.5 oz, 10 count. UPC 0 87848 42002 0 Food City brand, Low Carb Tortilla Whole Wheat, 13.5 oz.10 count. UPC 0 87848 42003 0 MFG Date 07/21/10 & MFG Date 07/22/10 stamped on the top left of the bag.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
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