Thread: FDA RECALLS Aug. 2009 UPDATED DAILY

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Frozen Culinary Circleâ„¢ Gourmet Macaroni And Cheese
Recalled Due To Possible Listeria Contamination

Contact:

Susie Bell
Susan.Bell@supervalu.com
952.828.4356

FOR IMMEDIATE RELEASE - August 14, 2009 - Minneapolis – SUPERVALU INC.® (NYSE:SVU) is voluntarily recalling frozen Culinary Circle™ Gourmet Macaroni and Cheese products because they may have the potential to be contaminated with listeria monocytogenes. The products are found in the frozen foods section in a 38 oz. package and were sold at SUPERVALU-owned stores including Acme®, Albertsons®, biggs®, Cub Foods®, Farm Fresh®, Hornbacher’s®, Jewel-Osco®, Lucky®, Shaw’s/Star Market™, Shop ‘n Save®, and Shoppers Food & Pharmacy® in all of the states where they operate.The possibility for contamination was identified through routine sampling of the product at the manufacturing facility. There have been no reported illnesses associated with the identified product. However, because the safety of customers is a top priority and out of an abundance of caution, SUPERVALU has voluntarily recalled the product. This product recall includes all: Product Name and Description: Culinary Circle Gourmet Macaroni and Cheese, a frozen product, 38 oz. package UPC#: 41130 38704 Customers who have purchased the affected product can bring it back to their SUPERVALU-owned store for a full refund or exchange. Customers with questions can contact SUPERVALU Inc. at 877.932.7948. Customers who have health-related concerns should contact their physician.

Page Last Updated: 08/18/2009
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

HomeAbout FDAContact UsA to Z Subject IndexSite MapWeb Site PoliciesFOIAAccessibility No FEAR Act

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Van's International Foods Issues Allergy Alert On Undeclared Wheat, Gluten, Milk And Egg In Wheat Free Homestyle Pancakes

Contacts:
(817) 329-3257 (24-hours)
Suzanne Miller, spm@spmcommunications.com
Alexandra Elliott, alexandra@spmcommunications.com
Tracy Aiello, tracy@spmcommunications.com

FOR IMMEDIATE RELEASE -- Vernon, CA -- August 19, 2009 -- Van's International Foods has issued an allergy alert and is voluntarily recalling the following product: 12.4 ounce package of frozen Van's Wheat Free Homestyle Pancakes with the lot number listed below because they contain undeclared wheat, gluten, milk and egg in the product.
People who have allergies or sensitivities to wheat, gluten, milk or eggs may run the risk of serious or life-threatening allergic reaction if they consume this product.

The 118 cases of recalled Van's Wheat Free Homestyle Pancakes may have been distributed in Maryland, Virginia, Pennsylvania, District of Columbia, New Jersey, New York, California, Arizona, Nevada, Utah, Washington, Oregon, Texas, Idaho and Hawaii, through retail outlets that include but may not be limited to Whole Foods, Wegmans, Giant Carlisle, Sprouts and Martins. The distributors and the retail customers involved have been notified.

The product comes in a 12.4 ounce package which is beige with an orange stripe on the top and a triangular blue gluten-free call out in the upper right-hand corner with the lot number 200060629B1 located on the side flap of the box. The "Best if used by" date is March 30, 2010 also printed on the same flap.

Package UPC Description – Retail Label Weight Lot # Best if Used By Date
0-89947-60604-9 Van's All Natural Wheat Free Homestyle Pancakes, 12.4 ounce 200060629B1 March 30, 2010

"Our customers have trusted Van's with their special dietary needs for more than 20 years, and their health and safety are our first priority," said CEO of Van's International Foods, Eric Kufel. "Van's has immediately implemented advanced quality procedures above and beyond what we already have in place to ensure the continued safety of our products."

The voluntary recall was initiated immediately after a packaging operator error, limited to one shift, was discovered. The company has immediately reinforced its Quality Assurance and Packaging procedures and believes that the problem was a one-time incident. Consumers who are allergic to or have sensitivity to wheat, gluten, milk or eggs, should not consume this product. Consumers should return the product to the place of purchase for a full refund or send the box top with the printed lot number to the address below to receive five free coupons for any Van's waffle, pancake, or French toast stick product 12.4 ounce or smaller.

Van's International Foods, Inc.
Attn: Wheat Free Pancake Product Recall
3285 East Vernon Avenue
Vernon, CA 90058

Consumers with questions may contact the company at (303) 848-6013 or via email at customerservice@vansintl.com . For more information on this recall, please visit www.vansfoods.com for details.

The Food and Drug Administration has been notified of this voluntary recall.

Page Last Updated: 08/21/2009
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

HomeAbout FDAContact UsA to Z Subject IndexSite MapWeb Site PoliciesFOIAAccessibility No FEAR Act

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and safety alerts from states as a service to consumers, the media, and other interested parties. FDA is not responsible for the content of these notices.

***CONSUMER ALERT***

Undeclared Sulfites in "Cleopatra Candy" Mixed Nuts

Contact:
Jessica Chittenden
518-457-3136

FOR IMMEDIATE RELEASE -- August 20, 2009 -- New York State Agriculture Commissioner Patrick Hooker today alerted consumers that Cleopatra Candy Inc., located at 1135 E 95th Street, Brooklyn, New York is recalling "Cleopatra Candy" Mixed Nuts 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.

The recalled "Cleopatra Candy" Mixed Nuts are packaged in an uncoded, 4 oz. plastic bag and is distributed in metropolitan New York and New Jersey. This packaged product also contains undeclared dried apricots, pineapple, papaya, banana chips and raisins.

Routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the product contained high levels of sulfites which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites.

No illnesses have been reported to date to this Department in connection with this product. Consumers who have purchased "Cleopatra Candy" Mixed Nuts should contact Nael Burqawi of Cleopatra Candy at (718) 649-8298.

Page Last Updated: 08/21/2009
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

HomeAbout FDAContact UsA to Z Subject IndexSite MapWeb Site PoliciesFOIAAccessibility No FEAR Act

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Quesos Mi Pueblito, LLT Issues a Recall on Mi Pueblito Queso Fresco Authentic Mexican Style Soft Cheese

Contact:
Martha Acevedo
973-473-4494

FOR IMMEDIATE RELEASE -- August 18, 2009 -- Passaic, NJ -- Quesos Mi Pueblito is recalling its Mi Pueblito Queso Fresco 14 oz., with Sell by Date 09/08/09, because it may contain listeria monocytogenes. This is 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 suffer only short-term symptoms, such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and still births among pregnant women.

The recalled cheese is distributed in the New Jersey/New York City area as well as, Delaware and Virgina, through Puebla Foods, Inc., Passaic, N. J. to retail stores and wholesalers.

The product comes in a 14 oz, clear plastic package, with a sell by label dated 09/08/09 on top, UPC code 2407710025.

No illnesses have been reported to date in connection with this problem.

The recall is a result of a sample collected by the NJ Dept. of Health and Senior Services.

Consumers who have purchased this product are urged to return them to the place of purchase for a full refund. Consumers with questions may call the company at 973-473-4494, Monday - Friday, 8:00 - 4:30 p. m.

Page Last Updated: 08/21/2009
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

HomeAbout FDAContact UsA to Z Subject IndexSite MapWeb Site PoliciesFOIAAccessibility No FEAR Act

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Nutracoastal Trading LLC Expands Its voluntary nationwide recall of Steam Dietary supplement
Contact:
David McLoughlin
(866) 803-2434

FOR IMMEDIATE RELEASE – Freeport, NY – August 21, 2009 – Nutracoastal Trading LLC announced today that it is expanding its July 28th, 2009 voluntary nationwide recall of the company's dietary supplement product sold under the following name: STEAM.

The Company has found by lab analysis that Lot 90260 contains Tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making STEAM DIETARY SUPPLEMENT an unapproved drug. The active drug ingredient is not listed on the product label. The undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.

The recalled product listed below was distributed in white plastic bottles to retail stores nationwide.

Brand Name Size Lot EXP. UPC

STEAM 1 Bottle – 5 Capsules 90260 6 11 8 52263 30033 1

No illnesses have been reported to the company to date in connection with this product.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

The FDA has been apprised of this action.

Nutracoastal Trading LLC, a Delaware Limited Liability Company, is committed to providing accurate information about its products because of concerns for the health and safety of consumers. It sincerely regrets any inconvenience to customers.

Consumers should return any unused product to the retail location where they were purchased or contact Nutracoastal Trading LLC directly at 866-803-2434 Monday – Friday, 9 am to 5 pm EDT.

Page Last Updated: 08/22/2009
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

HomeAbout FDAContact UsA to Z Subject IndexSite MapWeb Site PoliciesFOIAAccessibility No FEAR Act

Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Kroger Recalls Super Kids Enriched White Sandwich Bread Due to Undeclared Milk in the Product

Contact:
Media: Meghan Glynn
(513) 762-1304

FOR IMMEDIATE RELEASE – CINCINNATI, Ohio – August 21, 2009 – The Kroger Co. said today it is recalling Kroger brand Super Kids Enriched White Sandwich Bread sold in 13 states because it may contain milk not listed on the label. Customers should return the product to stores for a refund or replacement.

People who are allergic to milk could have a serious or life-threatening reaction if they consume this product. For consumers who are not allergic to milk, there is no safety issue with the product.

Kroger stores in the following states are included in this recall: Alabama, Georgia, Illinois, Indiana, Kentucky, Michigan, Missouri, North Carolina, Ohio, South Carolina, Tennessee, Virginia and West Virginia. Kroger stores in Arkansas, Louisiana, Mississippi and Texas are not included in the recall.

The recall also includes Jay C Food stores in Indiana and Food 4 Less stores in Illinois and Indiana. Other stores Kroger operates under different banner names are not included in this recall.

Item Description:

Kroger is recalling the following item:

Kroger Super Kids Enriched White Sandwich Bread sold in 20-ounce packages with the following UPC number: 1111000831 that list various “Best If Used Byâ€

FDA probes weight-loss pill alli over liver damage reports

Posted 41m ago

WASHINGTON (AP) — The Food and Drug Administration is investigating reports of liver damage in patients taking alli, the only nonprescription weight loss drug approved by the agency.

Regulators said Monday they have received more than 30 reports of liver damage in patients taking alli and Xenical, the prescription version of the drug. The reports, submitted between 1999 and October 2008, included 27 hospitalized patients, and six who suffered liver failure.

Alli and Xenical are both marketed by British drugmaker GlaxoSmithKline, though Xenical is manufactured by Swiss firm Roche.

The FDA says it has not established a direct relationship between the weight loss treatments and liver injury, and advised patients to continue using the drugs as directed.

"Consumers should consult their health care professional if they are experiencing symptoms," the agency said on its website. Signs of liver damage include fatigue, fever, nausea and vomiting.

FIND MORE STORIES IN: GlaxoSmithKline
The FDA said it's reviewing additional details about the suspected cases of liver injury submitted by manufacturers.

Roche referred questions to GlaxoSmithKline. Glaxo representatives did not immediately return calls for comment Monday afternoon.

The FDA first approved Xenical in 1999 and alli in 2007. The prescription pill is twice as potent as alli, which can be bought over the counter.

Glaxo reported $123 million in sales for alli last year, while Roche posted $472 million in revenue for Xenical.

In general, the FDA has started notifying the public earlier about possible safety issues with drugs, after coming under fire for acting too slowly on problems with blockbuster treatments like Merck's painkiller Vioxx.

Shares of London-based Glaxo fell 57 cents to $39.46 in afternoon trading.

http://www.usatoday.com/news/health/wei ... iver_N.htm

Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Quesos MI PUEBLITO, LLC Recalls Cheese Products Because of Possible Health Risk

Contact:
Martha Acevedo
(973) 473-4494

FOR IMMEDIATE RELEASE -- August 27, 2009 -- Quesos Mi Pueblito, LLC of Passaic, NJ is announcing a recall of the following cheese products with Sell by Date from February 2, 2009 to present:

LA FE OAXACA STRING CHEESE
EL VIEJITO OAXACA CHEESE
MI PUEBLITO COTIJA/AñEJO
MI PUEBLITO CUAJADA FRESCA
MI PUEBLITO QUESO COLOMBIANO DE ARRIERO
MI PUEBLITO QUESO MOLIDO
MI PUEBLITO QUESO COTIJA TRIANGULO
MI PUEBLITO QUESO FRESCO
MI PUEBLITO QUESO FRESCO DE RANCHO
MI PUEBLITO QUESO CASERO
MI PUEBLITO QUESO OAXACA
MI PUEBLITO REQUESON
MI PUEBLITO SERRANO

The cheese products may be contaminated with Listeria monocytogenes. This is 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 suffer only short-term symptoms, such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, infection can cause miscarriages and still births among pregnant women.

The recalled cheese was distributed in New Jersey, New York, Maryland, Delaware, and Virginia through Puebla Foods, INC., Passaic, N.J. to retail stores and wholesalers.

These products sizes and packages are as follows:



Brand Name USP/Size Packaging
LA FE OAXACA STRING CHEESE 0 23545 40115 6 / 14 oz. pack plastic package with sell-by label
EL VIEJITO OAXACA CHEESE 7 18122 18071 4 / 14 oz. pack, 10 lb. ball plastic package with sell-by label
MI PUEBLITO COTIJA/AñEJO 0 24077 10221 4/ vacuum packed in plastic wrap by weight plastic wrapped with sell-by label
MI PUEBLITO CUAJADA FRESCA 0 24077 10216 0 / 14 oz. pack plastic package with sell-by label
MI PUEBLITO QUESO COLOMBIANO DE ARRIERO 0 24077 10219 1 / 8 oz. pack plastic package with sell-by label
MI PUEBLITO QUESO MOLIDO 0 24077 10211 5 / 14 oz. pack plastic package with sell-by label
MI PUEBLITO QUESO COTIJA TRIANGULO 0 24077 10220 7 / 14 oz. pack plastic package with sell-by label
MI PUEBLITO QUESO FRESCO 0 24077 100258 / 14 oz. pack, 10 lb. ball plastic package with sell-by label
MI PUEBLITO QUESO FRESCO DE RANCHO 0 24077 10215 3 / 14 oz. pack plastic clam shell container, plastic wrap with sell-by label
MI PUEBLITO QUESO CASERO 0 24077 10222 1 / 14 oz. pack plastic clam shell container, plastic wrap with sell-by label
MI PUEBLITO QUESO OAXACA 0 24077 10224 5 / 14 oz. pack plastic package with sell-by label
MI PUEBLITO REQUESON 0 24077 10200 9 / 15 oz. pack plastic package with sell-by label
MI PUEBLITO SERRANO 0 24007 10200 0 / 16 oz. pack plastic package with sell-by label

No illnesses have been reported to date in connection with this problem.

The recall is a result of sampling and analyses by the NJ Dept. of Health and Senior Services.

Consumers who have purchased these products are urged to return them to the place of purchase for a full refund. Consumers with questions may call the company at 973-473-4494, Monday – Friday, 8:00 – 4 p.m.

Page Last Updated: 08/28/2009
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

HomeAbout FDAContact UsA to Z Subject IndexSite MapWeb Site PoliciesFOIAAccessibility No FEAR Act

***CONSUMER ALERT***

FDA posts press releases and other notices of recalls and safety alerts from states as a service to consumers, the media, and other interested parties. FDA is not responsible for the content of these notices.

Undeclared Sulfites in "Island Snacks Natures Mix"
Contact:
Jessica Chittenden
518-457-3136

FOR IMMEDIATE RELEASE - August 27, 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.

The recalled "Island Snacks Natures Mix" is packaged in a 6.5 oz. plastic bag that is coded with the date Jul 24, 2010. The product was offered for sale at Kmart stores in Western New York State.

Routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the product contained high levels of sulfites which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites.

No illnesses have been reported to date to this Department in connection with this product. Consumers who have purchased "Island Snacks Natures Mix" should contact Brian Lauber of Snack King Foods at (585) 415-2944.

Page Last Updated: 08/29/2009
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

HomeAbout FDAContact UsA to Z Subject IndexSite MapWeb Site PoliciesFOIAAccessibility No FEAR Act

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Voluntary Prodcut Recall: Chef Pierre® Gourmet Lemon Meringue Pie, Day Code 9159 Only

Contact:
Mike Cummins, Chef Pierre, +1.630.598.8412
Ashley LaCroix, Chef Pierre, +1.630.598.8732

FOR IMMEDIATE RELEASE -- August 28, 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.

The item included in the voluntary recall is part of a partial production run only for Chef Pierre Lemon Meringue Pie with the UPC CODE 3210009293 AND a code of 9159 printed on the top of the pie label directly under the Chef Pierre logo.

No other Chef Pierre branded products are affected by this voluntary recall. Only packages labeled as Chef Pierre Lemon Meringue Pie with the UPC CODE 3210009293 AND a code of 9159 printed on the top of the pie label directly under the Chef Pierre logo is part of this recall.

This product was sold and distributed nationally to foodservice companies and sold to consumers through foodservice retail outlets and other foodservice establishments.

Chef Pierre has received no reports of illnesses or allergic reactions.

This recall is being conducted in conjunction with the Food and Drug Administration (FDA).

Consumers may return affected product to the store or operator where it was purchased for a full refund. Consumers or customers who may have questions or concerns should call the special Chef Pierre pie recall toll-free consumer line at 1.888.891.6100. The consumer line is available from 7:00 a.m. to 6:00 p.m. Central Time, Monday through Friday.

Page Last Updated: 08/29/2009
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

HomeAbout FDAContact UsA to Z Subject IndexSite MapWeb Site PoliciesFOIAAccessibility No FEAR Act