Recall Roundup: June 2009

Tuesday, June 30, 2009

Kroger Recalls Three Seasonings Due to Possible Health Risk

/PRNewswire/ -- The Kroger Co. said today it is recalling Kroger Popcorn Seasoning Movie Theater Butter Flavored, Kroger Popcorn Seasoning White Cheddar Flavored, and Kroger Fat Free Butter Flavored Sprinkles sold in some of its retail stores because the Company has been made aware by a supplier that an ingredient in the product may have been contaminated with Salmonella.

No illnesses have been reported in connection with the Kroger products.

Stores the company operates under the following names did not receive any of the seasonings being recalled: Ralphs, Smith's, Fred Meyer, QFC, Fry's, King Soopers, City Market, and Foods Co.

Kroger is recalling the following items:

-- Kroger Popcorn Seasoning Movie Theater Butter Flavored sold in
2.82-ounce jars with a sell-by date of JUN 08 10 under the following
UPC code: 011110 72445.
-- Kroger Popcorn Seasoning White Cheddar Flavored sold in 2.82-ounce
jars with a sell-by date of JUN 09 10 under the following UPC code:
011110 72444. These two seasonings were sold in Kroger stores in Ohio,
Indiana, Illinois, Kentucky, Michigan, Missouri, North Carolina, South
Carolina, Tennessee, West Virginia and Virginia; Dillons and Gerbes
stores in Kansas and Missouri; Baker's stores in Nebraska; and Food 4
Less, Hilander, Jay C, Owen's, Pay Less and Scott's stores in Illinois
and Indiana.
-- Kroger Fat Free Butter Flavored Sprinkles sold in 2-ounce jars with
sell-by dates of JUN 08 10 and JUN 09 10 under the following UPC code:
011110 66853. This seasoning was sold in Kroger stores in Alabama,
Arkansas, Georgia, Kentucky, Louisiana, Mississippi, Missouri, North
Carolina, South Carolina, Tennessee, Texas, Virginia and West
Virginia.

Customers who have purchased the above products should not consume them and should return them to a store for a full refund or replacement.

Salmonella is an organism that can cause serious and sometimes fatal infections, particularly in young children, the elderly, and persons with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and/or abdominal pain. For more information, please visit the Centers for Disease Control and Prevention's website at www.cdc.gov.

Consumers who have questions about this recall may contact Kroger toll-free at (800) 632-6900. For more information, please visit www.kroger.com/recalls.

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Thursday, June 25, 2009

Big Muddy Motor Sports Recalls Generators Due to Fire Hazard

DEWALT Recalls Framing Nailers Due to Serious Injury Hazard

Violation of Federal Mattress Flammability Standard Prompts Recall by Loyal Bedding of Mattress Sets

Wednesday, June 24, 2009

Crane Plumbing Recalls Bath Tubs With A Whirlpool Due to Entrapment and Drowning Hazards

Applica Consumer Products Inc. Recalls Spacemaker(tm) Coffeemakers Due to Burn Hazard

Diving Wings With Defective Inner Bladders Recalled by Poseidon Due to Drowning Hazard

Loaded Boards Recalls Orangatang Skateboard Wheels; Blow-outs Pose Risk of Injury to Riders

Tuesday, June 23, 2009

Some imported Honey Jujube teas recalled for preservatives not found on product label

Georgia Agriculture Commissioner Tommy Irvin alerts consumers to the recall of some imported teas.

Seoul Shik Poom Inc., Englewood, NJ, is recalling its 2.2 lb packages of “Honey Jujube Teas” because they may contain sulfites, a preservative that is not listed as an ingredient on the product label.

People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

The recalled “Honey Jujube Teas” were sold in retail stores nationwide.
The product comes in 2.2 lb, clear glass jar marked with code #TC1607 and UPC CODES: 0761898630358 on the label and with an expiration date of 08/13/2009, 11/26/2009, 05/26/2010, 08/18/2010, 10/02/2010, 01/15/2011, 03/09/2011 stamped on the top cover.

Consumers with the product may return it to place of purchase for a full refund. Those with questions may contact Seoul Shik Poom at (201) 567-7780.

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Saturday, June 20, 2009

Unlisted eggs cause soup mix recall

Georgia Commissioner of Agriculture Tommy Irvin is alerting consumers with an allergy or sensitivity to eggs to the recall of a kosher soup mix.

Unilever United States, Inc. is voluntarily recalling Knorr® Kosher Soup Mix – Chicken Vegetable Flavor with Pasta (imported from Israel) because it contains eggs without listing them on the label. Persons who have an allergy or severe sensitivity to egg run the risk of a serious or life-threatening allergic reaction if they consume this product.

The soup mix is packed in a 2.18 oz (62 g) pouch. Its UNIT UPC is 4800170660 (located on the back of the pouch under the bar code). The recall includes all "BEST-IF-USED-BY" dates (located on a panel next to the UPC). The product was distributed nationwide.

Consumers who have the recalled soup mix are asked to discard it and call 877-270-7412, which is operational 24 hours a day, for information on the recall and to request a full refund. A company consumer services representative is available between 8:30 AM and 6:00 PM EDT. No other Knorr® products are affected by this recall.

Georgia Department of Agriculture sanitarians will be checking grocery store shelves and food warehouses to make sure the recalled soup mix is removed from sale.

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Nestle U.S.A. Recalls Nestle Toll House(R) Refrigerated Cookie Dough

/PRNewswire/ -- As part of a nationwide manufacturer's recall, The Giant Food Company today removed all varieties of Nestle TOLL HOUSE(R) Refrigerated Cookie Dough from store shelves. Nestle U.S.A. announced a voluntary recall of the refrigerated cookie dough in response to consumer illness complaints which may be linked to the consumption of the product in raw, uncooked form.

The recalled products include:

Chocolate Chip tube 32oz 0 50000 00400 3
Ultimates Chocolate Chip with Caramel Filling bar
16oz 0 50000 44066 5
Ultimates Chocolate Chip with Chocolate Filling bar
16oz 0 50000 44069 6
Chocolate Chip bar 16.5oz 0 50000 62231 3
Chocolate Chip tub 40oz 0 50000 62246 7
Chocolate Chip tube 16.5oz 0 50000 62239 9
Halloween Swirled Fudgy Brownies bar 18oz 0 50000 00088 3
Christmas Shapes Sugar Cookies 15.5oz 0 50000 00505 5
Easter Brownie Bar 18oz 0 50000 00518 5
Halloween Sugar Shapes 15.5oz 0 50000 00829 2
Halloween Swirled Chocolate Chip bar 16oz 0 50000 00929 9
Christmas Swirled Chocolate Chip bar 16oz 0 50000 00930 5
Easter Swirled Chocolate Chip bar 16oz 0 50000 00932 9
Red, White & Blue Swirled Choc Chip bar 16oz 0 50000 00937 4
Valentine Hearts Sugar Cookies 13.5oz 0 50000 44056 6
Easter Bunnies Sugar Cookies 13.5oz 0 50000 44058 0
Valentine Swirled Chocolate Chip bar 16oz 0 50000 00931 2

These products should not be consumed. Customers who have purchased the product should return any unused portions or bring their purchase receipt to any Giant Supermarket for a full refund. Consumers with questions are encouraged to contact Nestle U.S.A. at 1-800-559-5025.

The CDC and several State Health Departments are investigating an outbreak of E. coli infections that is possibly linked to the recalled products. So far no product has tested positive, and the investigation is ongoing.

Symptoms of E. coli O157:H7 exposure could include stomach cramps and diarrhea, including diarrhea with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. If any of the described symptoms are exhibited, medical attention should be sought.

To date, Giant has not received any reports of illnesses associated with consumption of these products. Customers may call Giant Customer Service at (888) 469-4426 Monday through Friday from 9 a.m. to 5 p.m. for more information. Customers can also visit the Giant Web site at www.giantfood.com.

Friday, June 19, 2009

SmartSpark Energy Systems Recalls Battery Equalizers Due to Fire Hazard

Body Boards Recalled by JGR Copa Due to Violation of Lead Paint Standard

Tuesday, June 16, 2009

Hi-Tech Pharmaceuticals, Inc. Issues Nationwide Recall of All Lots of Stamina-Rx Dietary Supplement Products

Hi-Tech Pharmaceuticals, Inc. (“Hi-Tech”), 6015-B Unity Dr., Norcross, GA 30071, announced today that it is conducting a nationwide voluntary recall of the company's product sold under the name Stamina-Rx.

On May 1, 2009, Hi-Tech was notified by the Food and Drug Administration (FDA) that FDA's lab analysis of one lot of Stamina-Rx samples found that the product contained the undeclared ingredient − benzamidenafil − a Phosphodiesterase Type 5 (PDE5) inhibitor. The lot number found to contain benzamidenafil is Lot 08141578, Exp. 9/10. Benzamidenafil is in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED). Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil 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 and may be most susceptible to adverse effects from this product.

Stamina-Rx is sold predominantly in health food and drug stores nationwide. The product is sold in 10, 30, and 40-tablet bottles and in 2 and 6-tablet blister packs.

In addition to the one lot described above, Hi-Tech is recalling all other lots of Stamina-Rx because it is an unapproved new drug and misbranded new drug in violation of the Federal Food, Drug and Cosmetic Act (the Act). FDA notified Hi-Tech that, based on certain labeling claims made by the firm, Stamina-Rx is a drug as defined in the Act. Stamina-Rx is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. The labeling at issue was not on bottles of Stamina-Rx, but was contained in certain web-based and print media.

Hi-Tech has been under a Consent Decree of Permanent Injunction with FDA since September 23, 2003. In accordance with the Decree, FDA determined that additional corrective actions were necessary for Hi-Tech to achieve compliance with the Act and the Decree and therefore, on May 1, 2009 FDA ordered Hi-Tech to recall all lots of Stamina-Rx to the consumer level.

Customers who have this product in their possession should stop using it immediately. Any adverse events that may be related to the use of this product should be reported to Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM - 5:00 PM EST.

The public is encouraged to submit a report of any serious adverse events that occur with the use of Stamina-Rx to FDA’s MedWatch Adverse Event Reporting program online at [www.fda.gov/MedWatch/report.htm] or 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 20853-9787 or fax [1-800-FDA-0178].

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Laceration Hazard Prompts Recall by Starbucks of Coffee Grinders; Made by Tsann Kuen

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Starbucks Barista(r) Blade Grinders and Seattle's Best Coffee(r) Blade Grinders

Units: About 530,000

Importer: Starbucks Coffee Co., of Seattle, Wash.

Manufacturer: Tsann Kuen (Zhangzhou) Enterprise Co. Ltd. ("TKL"), of China

Hazard: The grinder can fail to turn off or can turn on unexpectedly, posing a laceration hazard to consumers.

Incidents/Injuries: The firm has received 176 reports of grinders that failed to turn off or that turned on unexpectedly, including three reports of hand lacerations that occurred when the grinders turned on unexpectedly during cleaning.

Description: This recall includes the Starbucks Barista(r) Blade Grinders and Seattle's Best Coffee(r) Blade Grinders with the following colors and SKU numbers:

Brand --- Color --- SKU #
Starbucks Barista(r) Blade Grinder --- Stainless Steel --- 171884
Starbucks Barista(r) Blade Grinder --- Green --- 195234
Starbucks Barista(r) Blade Grinder --- Pink --- 195235
Starbucks Barista(r) Blade Grinder --- Orange --- 220623
Starbucks Barista(r) Blade Grinder --- Teal --- 220624
Starbucks Barista(r) Blade Grinder --- Cranberry --- 242275
Starbucks Barista(r) Blade Grinder --- Olive --- 344476
Starbucks Barista(r) Blade Grinder --- Black --- 454482
Seattle's Best Coffee(r) Blade Grinder --- Brown Metallic --- 474881

Sold at: Starbucks and Seattle's Best Coffee stores nationwide from March 2002 through March 2009 for about $30.

Manufactured in: China

Remedy: Consumers should immediately stop using the coffee grinders and contact Starbucks to receive a free replacement grinder.

Consumer Contact: For additional information, contact Starbucks toll free at (866) 276-2950 between 9 a.m. and 9 p.m. MT or visit the company's Web site at www.starbucks.com .

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Viking Range Corporation Recalls Built-In Refrigerators Due to Injury Hazard; Doors Can Detach

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Viking Built-In Side-by-Side Refrigerator/Freezers and Refrigerators with Bottom Freezers

Units: About 45,000

Manufacturer: Viking Range Corporation, of Greenwood, Miss.

Hazard: The refrigerator's doors can detach, posing an injury hazard to consumers.

Incidents/Injuries: Viking has received about 57 reports of doors detaching, including four reports of injuries involving bruises, broken toes/fingers, and strains. Also, several incidents of minor damage to floors and counters have been reported.

Description: This recall involves Viking built-in 48-inch wide side-by-side refrigerator/freezers and the built-in 36-inch wide refrigerators with bottom freezers with model and serial numbers with date codes listed below. The refrigerators come in stainless steel and various colors and wood finishes and are built into the kitchen cabinetry. "Viking" is written on the front of the refrigerator. The model and serial numbers are located either behind the produce drawer or on the ceiling of the interior of the refrigerators. The 42-inch wide or freestanding refrigerators are not included in this recall.

Model Numbers Starting With --- Date Codes

VCSB481, VCSB482, DDSB482, DFSB482, DTSB482, DDBB362, VCBB360, VCBB362, DFBB362, DTBB362, DTBB363 --- All units
VCSB483, DDSB483, DFSB483, DTSB483 --- Date codes before 030104
VCSB483D, DDSB483D, DFSB483D --- Date codes before 030105
VCBB363 --- Date codes before 102005
DDBB363 --- Date codes before 112305
DFBB363 --- Date codes before 041006

The first six numbers in the serial number are the manufacture date of the unit in [mm][dd][yy] format, e.g., serial number 051903G0000000375 was manufactured on May 19, 2003 and serial number F01250210170 was manufactured on January 25, 2002.

Sold by: Appliance and specialty retailers nationwide from July 1999 through April 2006 for between $4,725 and $6,400.

Manufactured in: United States

Remedy: Consumers with recalled refrigerators should contact Viking immediately to schedule a free in-home repair. Consumers should immediately stop using the recalled refrigerator if the door isn't sealing properly, is sagging, or fails to open and close properly. If the door is functioning properly, consumers may continue to use the refrigerator until it has been repaired.

Consumer Contact: For more information, contact Viking toll-free at (888) 345-2650 from 8 a.m. to 5 p.m. ET Monday through Friday or visit Viking's Web site at www.vikingrange.com .

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Monday, June 15, 2009

FDA Issues Public Health Advisory Regarding Levemir Insulin

The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.

The FDA has received one report of a patient who suffered an adverse event due to poor control of glucose levels after using a vial from one of these three lots.

The agency is advising patients who use Levemir insulin to:

1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038. Patients can locate the lot number on the side of the box of insulin and also on the side of the vial.

2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your healthcare provider as another insulin product may require adjustments in dosing.

3. Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.

4. Contact the Novo Nordisk Customer Care Center at 800-727-6500 for what to do with vials from these lots or if you have any other questions.

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Torres Hillsdale Country Cheese LLC Announces the Recall of all lots of Soft Mexican Cheeses due to Possible Listeria Contamination

Torres Hillsdale Country Cheese of Reading, Michigan announces the recall of all lots of various types of soft Mexican-style cheeses due to potential Listeria contamination. Consumption of food contaminated with Listeria monocytogenes can cause Listeriosis, an uncommon but potentially fatal disease. Listeriosis can cause high fever, severe headache, neck stiffness and nausea. Listeriosis can also cause miscarriages and stillbirths. The very young, the pregnant, the elderly and persons with compromised immune systems are the most susceptible to infection. People experiencing these problems should seek immediate medical attention.

A sample of queso fresco cheese, taken by an investigator from the U.S. Food and Drug Administration on May 26, 2009, was subsequently tested by an FDA laboratory and discovered to be contaminated with Listeria monocytogenes.

The products were distributed to retails stores and delis in the following states: Illinois, Indiana, Michigan, Georgia, Tennessee, Kentucky, North Carolina, South Carolina, Ohio and Wisconsin.

The products were sold under the name 'Aguas Calientes' as follows:

Product Unit Size
Queso Asadero 12 oz and 10 lb ball
Queso Oaxaca 10 lb ball
Queso Fresco 1 lb and 8 oz.
Queso Requeson 1 gallon pail and 3 gallon pail
Morral Adobera 3 lb packages

Packaging may also include a label with the name "Torres Hillsdale Country Cheese LLC". The recall encompasses all expiration dates.

No illnesses have been reported to date in connection with the recalled products.

Consumers and retailers are urged to return all unused recalled product to the manufacturer. Consumers with questions may contact Salvador Torres, Manager, Torres Hillsdale Country Cheese LLC at 517-368-5990, Monday through Friday between 7 a.m. and 3 p.m. EDT.

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Thursday, June 11, 2009

Six Reported Deaths Prompt Urgent Re-announcement of Blair Recall of Women's Chenille Robes

The U.S. Consumer Product Safety Commission (CPSC) and Blair LLC, of Warren, Pa., are re-announcing the voluntary recall by Blair of 162,000 women's full length Chenille Robes. Since the recall was originally announced in April 2009, Blair has received reports of six deaths due to the robes catching on fire. Five of the six victims were female, and all five were cooking at the time of the incidents. Three of the victims were in their 80s.

CPSC and Blair announced the recall for the robes after Blair learned of three robes catching on fire, including one report of second-degree burns. Blair was subsequently made aware of the fatalities after the recall was announced and after Blair had sent letters of the recall to consumers who purchased the robes.

The Women's Chenille Robes have the following item numbers: 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. The item number is identified on a label in the garment's neckline. The robe is a one-piece garment made of plush sculpted chenille, a shaped stand collar, and horizontal chenille front and back yolks and cuffs. The robe has a full-button front with seven matching button closures, long sleeves with self cuffs, a straight bottom with self hem, and two sideseam pockets. The robe's sewn in label states: "100% Cotton, RN 81700, Made in Pakistan".

The robes were sold in Blair catalogs and Web site, and Blair stores in Warren, Pa., Grove City, Pa., and Wilmington, Del., from January 2003 through March 2009 from about $20 to $40.

CPSC and Blair once again urge consumers to stop wearing the garments immediately and contact Blair LLC for information on returning the robe and to receive a refund or a $50 gift card for Blair merchandise. Contact Blair toll-free at (877) 392-7095 between 9 a.m. and 9 p.m. ET Monday through Saturday, visit the firm's Web site at www.blair.com/recall, or contact the firm by e-mail at blairproductrecall@blair.com

"CPSC urges all consumers to report any incidents or injuries involving consumer products, even after a recall has been announced," said Acting CPSC Chairman Thomas Moore. "Contact the CPSC so that we may help prevent tragic deaths or injuries like those that might be related to the Blair robes."

Wednesday, June 10, 2009

Children's Hooded Sweatshirts with Drawstrings Recalled by Winterbee Due To Strangulation Hazard

LaJobi Recalls Babi Italia Pinehurst and Bonavita Hudson Drop Side Cribs; Risk of Entrapment and Suffocation

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Bonavita "Hudson" and Babi Italia "Pinehurst" Drop Side Cribs

Units: About 2,900

Importer: LaJobi Inc., of Cranbury, N.J.

Hazard: The lower spring pins on the footboard and headboard can pop out of the tracks located on the drop side causing the drop side to detach from the crib. When the drop side detaches, it creates a hazardous gap between the drop side and the crib mattress in which infants and toddlers can become entrapped and suffocate or fall from cribs.

Incidents/Injuries: CPSC and LaJobi have received a total of 33 reports of drop side detachment due to spring pin failure. In these reports, two children became entrapped and one child fell from cribs. Both entrapped children were freed by caregivers, one child was bruised.

Description: The recalled cribs are wood with a metal mattress support and have drop sides and were sold in a variety of finishes including cherry, espresso, natural, and white. Hudson and Pinehurst drop side cribs with production dates from December 2006 through August 2007 are included in the recall. The recalled cribs have the production date, product order (PO) number, item number, and color printed on a label attached to the footboard or headboard.

Sold at: Babi Italia Pinehurst drop side cribs were sold exclusively by Babies "R" Us. Bonavita Hudson drop side cribs were sold at Baby Basics, Beautiful Beginnings, and Buy Buy Baby stores and children's product stores nationwide for about $300. Cribs were sold from December 2006 through December 2007.

Manufactured in: China

Remedy: CPSC urges parents and caregivers to immediately stop using the recalled cribs and find an alternative, safe sleeping environment for their baby. LaJobi will provide professional technicians to perform in-home installations of a free retrofit hardware kit. Consumers should contact LaJobi to register for the free retrofit kit service.

Consumer Contact: For additional information, contact Lajobi toll-free at (866) 688-9009 anytime, or visit the firm's Web site at www.Lajobi.com

Note: This recall does not apply to the LaJobi crib models with straight pins on the headboard and footboard or non drop side cribs.

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LaJobi Recalls Bonavita "Cabana" Drop Side Cribs Due To Entrapment and Strangulation Hazards

Tuesday, June 9, 2009

FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs

Patients Still Have Access to Approved Narcotics for Pain Relief

The U.S. Food and Drug Administration today warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain.

The FDA's warning letters notified the companies they may be subject to enforcement action if they do not stop manufacturing and distributing prescription unapproved products that include high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. This action does not include oxycodone capsules.

Those companies receiving warning letters are Boehringer Ingelheim Roxane, Inc., Columbus, Ohio; Cody Laboratories, Inc., Cody, Wyoming; Glenmark Pharmaceuticals Inc., Mahwah, N.J.; Lannett Company, Inc., Philadelphia; Lehigh Valley Technologies, Inc., Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group, St. Louis; Physicians Total Care Inc., Tulsa, Okla.; Roxane Laboratories Inc., Columbus, Ohio; and Xanodyne Pharmaceuticals Inc., Newport, Ky.

The warning letters are part of the FDA's initiative on marketed unapproved drugs announced in June 2006. At that time, the agency published a compliance policy guide describing its risk-based enforcement approach against illegally marketed unapproved drugs.

"Consumers have a right to expect that their drugs meet the FDA's safety and effectiveness standards," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality."

Consumers who rely on narcotics for pain relief continue to have access to narcotic products that the agency has evaluated and determined to be safe and effective. The FDA has determined that removal of the unapproved narcotic products will not create a shortage for consumers.

Consumers who may be concerned that they are taking any of these products should refer to the FDA's Unapproved Drugs Web page, which includes a list of manufacturers of these products. These consumers should consult a health care professional for detailed guidance on treatment options.

"We will continue to take aggressive action against those firms that do not have the required FDA approval for their drugs," said Deborah M. Autor, J.D., director of CDER's Office of Compliance. "Today's warning letters are another demonstration of our commitment to remove illegal, unapproved drugs from the market."

Manufacturers have 60 days to stop manufacturing these products. Distributors have 90 days to stop shipping existing products. Previously manufactured products may still be found on pharmacy shelves for a short time.

To view copies of the Warning Letters, the names of the companies and their affected products, see the FDA's Unapproved Drugs Web page at: http://www.fda.gov/cder/drug/unapproved_drugs/enforcement.htm#narcotics

Information on FDA-approved drugs

Drugs Marketed in the United States That Do Not Have Required FDA Approval: http://www.fda.gov/cder/drug/unapproved_drugs

If you would like to hear a replay of the FDA's telebriefing on this issue, callers in the United States and Canada may dial 1-888-566-0502. International callers may dial 1-203-369-3058. The replay will be available until April 6, 2009 at 11:59 p.m. EDT.
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FDA Alerts Consumers to Recall of Certain Pistachios

FDA and California Inspectors Identify Salmonella

The FDA and the California Department of Public Health (CDPH) are investigating Salmonella contamination in pistachio products sold by Setton Pistachio of Terra Bella Inc, Calif. The company has stopped all distribution of processed pistachios and will issue a voluntary recall involving approximately 1 million pounds of its products. Because the pistachios were used as ingredients in a variety of foods, it is likely this recall will impact many products. In addition, the investigation at the company is ongoing and may lead to additional pistachio product recalls.
The contamination involves multiple strains of Salmonella. Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Thus far, several illnesses have been reported by consumers that may be associated with the pistachios. It is not yet known whether any of the Salmonella strains found in the pistachio products are linked to an outbreak. The FDA is conducting genetic testing of the samples to pursue all links.

Until FDA is able to provide more information, consumers should not eat pistachios or food products containing them (such as pistachio bakery goods and pistachio ice cream) unless they can determine that the products do not contain pistachios from Setton Pistachio of Terra Bella, Inc. ("Setton").

FDA will provide a searchable database of affected products at http://www.fda.gov/pistachios/ and will continue to update the public.

FDA first learned of the problem on March 24, when it was informed by Kraft Foods that its Back To Nature Trail Mix was found to be contaminated with Salmonella. Kraft had identified the source of the contamination to be pistachios from Setton and conducted a recall.
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Raw Alfalfa Sprouts Linked to Salmonella Contamination

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) today recommended that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts, until further notice because the product has been linked to Salmonella serotype Saintpaul contamination. Other types of sprouts have not been implicated at this time.

The investigation indicates that the problem may be linked to contamination of seeds for alfalfa sprouts. Because suspect lots of seeds may be sold around the country and may account for a large proportion of the alfalfa seeds currently being used by sprout growers, and cases of illness are spread across multiple states, FDA and CDC are issuing this general advisory.

FDA will work with the alfalfa sprout industry to help identify which seeds and alfalfa sprouts are not connected with this contamination, so that this advisory can be changed as quickly as possible.

CDC, FDA and six State and local authorities have associated this outbreak with eating raw alfalfa sprouts. Michigan, Minnesota, Pennsylvania, South Dakota, Utah, and West Virginia have reported 31 cases of illness with the outbreak strain of Salmonella Saintpaul to CDC. Most of those who became ill reported eating raw alfalfa sprouts. Some reported eating raw sprouts at restaurants; others reported purchasing the raw sprouts at the retail level.

The illnesses began in mid-March. Cases are still being reported, and possible cases are in various stages of laboratory testing, so illnesses may appear in other states. No deaths have been reported. The number of infected people may be higher than currently reported because some illnesses have not yet been confirmed with laboratory testing.

The CDC and FDA recommend at all times that persons at high risk for complications, such as the elderly, young children, and those with compromised immune systems, not eat raw sprouts because of the risk of contamination with Salmonella or other bacteria. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals 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 meningitis and bone infections.

Initial investigation results trace the contaminated raw alfalfa sprouts to multiple sprout growers in multiple states. This suggests a potential problem with the seeds used, as well as the possible failure of the sprout growers involved to appropriately and consistently follow the FDA Sprout Guidance issued in 1999. The guidance recommends an effective seed disinfection treatment immediately before the start of sprouting (such as treating seed in 20,000 parts per million Calcium hypochlorite solution with agitation for 15 minutes) and regularly testing the water used for every batch of sprouts for Salmonella and E coli O157:H7 contamination.

This outbreak appears to be an extension of an earlier outbreak in 2009. In February and March, an outbreak of Salmonella Saintpaul infections occurred in Nebraska, South Dakota, Iowa, Kansas, and Minnesota. This outbreak was linked to raw alfalfa sprouts, and the outbreak strain was indistinguishable from that of these recently reported cases. A separate outbreak of Listeria monocytogenes infections was also linked to sprouts in 2009. In the 1990s, a number of outbreaks related to sprouts led FDA to issue its guidance. Experience over the past decade has shown that the likelihood of Salmonella in sprouts can be minimized when recommendations from FDA’s Sprout Guidance are followed.

Preventive controls are very important in the growing of all raw sprouts. FDA reminds sprout growers to be vigilant in their food safety practices and strongly encourages sprout growers to follow the Agency’s Sprout Guidance. Additionally, the United Fresh Produce Association has advised all of its members to follow FDA’s guidance on sprouts. FDA appreciates that the produce industry has reinforced this message and reminds retailers that it is prudent to sell sprouts from growers who follow FDA's recommendations.

For persons who continue to eat sprouts, visit (U.S. Food and Drug Administration, 2002 consumer advisory, available at http://www.cfsan.fda.gov/~lrd/tpsprout.html).
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Thursday, June 4, 2009

Children's Loungewear Recalled by Warm Biscuit Bedding Due to Violation of Federal Flammability Standards

Wednesday, June 3, 2009

Hair Dryers Recalled by Vintage International Due to Electrocution Hazard

Bicycles Recalled by REI Due to Fork Failure

Bugaboo Recalls Strollers Due to Risk of Brake Failure

Tuesday, June 2, 2009

Nutro Products Announces Voluntary Recall of Limited Range of Dry Cat Food Products

Recently, Nutro Products announced a voluntary recall of select varieties of NUTRO® NATURAL CHOICE® COMPLETE CARE® Dry Cat Foods and NUTRO® MAX® Cat Dry Foods with “Best If Used By Dates” between May 12, 2010 and August 22, 2010. The cat food is being voluntarily recalled in the United States and ten additional countries. This recall is due to incorrect levels of zinc and potassium in our finished product resulting from a production error by a US-based premix supplier.

Two mineral premixes were affected. One premix contained excessive levels of zinc and under-supplemented potassium. The second premix under-supplemented potassium. Both zinc and potassium are essential nutrients for cats and are added as nutritional supplements to NUTRO® dry cat food.

This issue was identified during an audit of our documentation from the supplier. An extensive review confirmed that only these two premixes were affected. This recall does not affect any NUTRO® dog food products, wet dog or cat food, or dog and cat treats.

Affected product was distributed to retail customers in all 50 states, as well as to customers in Canada, Mexico, Japan, Korea, Thailand, Malaysia, Singapore, Indonesia, New Zealand, and Israel. We are working with all of our distributors and retail customers, in both the US and internationally, to ensure that the recalled products are not on store shelves. These products should not be sold or distributed further.

Consumers who have purchased affected product should immediately discontinue feeding the product to their cats, and switch to another product with a balanced nutritional profile. While we have received no consumer complaints related to this issue, cat owners should monitor their cat for symptoms, including a reduction in appetite or refusal of food, weight loss, vomiting or diarrhea. If your cat is experiencing health issues or is pregnant, please contact your veterinarian.

Consumers who have purchased product affected by this voluntary recall should return it to their retailer for a full refund or exchange for another NUTRO® dry cat food product. Cat owners who have questions about the recall should call 1-800-833-5330 between the hours 8:00 AM to 4:30 PM CST, or visit www.nutroproducts.com.

Recalled Pet Food

The varieties of NUTRO® NATURAL CHOICE® COMPLETE CARE® Dry Cat Foods and NUTRO® MAX® Cat Dry Foods listed below with “Best If Used By Dates” between May 12, 2010 and August 22, 2010 are affected by this voluntary recall.

Nutro Products Recall List – Dry Cat Foods

U.S. Product Name	Bag Size	UPC
NUTRO® NATURAL CHOICE® COMPLETE CARE® Kitten Food	4 lbs	0 79105 20607 5
NUTRO® NATURAL CHOICE® COMPLETE CARE® Kitten Food	8 lbs.	0 79105 20608 2
NUTRO® NATURAL CHOICE® COMPLETE CARE® Kitten Food (Bonus Bag)	9.2 lbs.	0 79105 20695 2
NUTRO® NATURAL CHOICE® COMPLETE CARE® Kitten Food	20 lbs	0 79105 20609 9
NUTRO® NATURAL CHOICE® COMPLETE CARE® Kitten Food (Sample Bag)	1.5 oz	none
NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult	4 lbs	0 79105 20610 5
NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult	8 lbs.	0 79105 20611 2
NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult (Bonus Bag)	9.2 lbs	0 79105 20694 5
NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult	20 lbs	0 79105 20612 9
NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult (Sample Bag)	1.5 oz	none
NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult Oceanfish Flavor	4 lbs	0 79105 20622 8
NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult Oceanfish Flavor	8 lbs	0 79105 20623 5
NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult Oceanfish Flavor (Bonus Bag)	9.2 lbs.	0 79105 20698 3
NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult Oceanfish Flavor	20 lbs	0 79105 20624 2

NUTRO® MAX® Cat Adult Roasted Chicken Flavor	3 lbs	0 79105 10228 5
NUTRO® MAX® Cat Adult Roasted Chicken Flavor	6 lbs	0 79105 10229 2
NUTRO® MAX® Cat Adult Roasted Chicken Flavor	16 lbs	0 79105 10230 8
NUTRO® MAX® Cat Adult Roasted Chicken Flavor (Sample Bag)	1.5 oz	none
NUTRO® MAX® Cat Indoor Adult Roasted Chicken Flavor	3 lbs	0 79105 10243 8
NUTRO® MAX® Cat Indoor Adult Roasted Chicken Flavor	6 lbs	0 79105 10244 5
NUTRO® MAX® Cat Indoor Adult Roasted Chicken Flavor	16 lbs	0 79105 10245 2
NUTRO® MAX® Cat Indoor Adult Roasted Chicken Flavor (Sample Bag)	1.5 oz	none
NUTRO® MAX® Cat Indoor Adult Salmon Flavor	3 lbs	0 79105 10246 9
NUTRO® MAX® Cat Indoor Adult Salmon Flavor	6 lbs	0 79105 10247 6
NUTRO® MAX® Cat Indoor Adult Salmon Flavor	16 lbs	0 79105 10248 3
NUTRO® MAX® Cat Indoor Weight Control	3 lbs	0 79105 10249 0
NUTRO® MAX® Cat Indoor Weight Control	6 lbs	0 79105 10250 6
NUTRO® MAX® Cat Indoor Weight Control	16 lbs	0 79105 10251 3

LeClerc Foods Announces a Limited Nationwide Voluntary Recall of Market Pantry Chocolate Chip Chewy Granola Bars due to Unlabeled Peanut Allergen

Leclerc Foods has initiated a limited voluntary recall of a single lot of Market Pantry Chocolate Chip Chewy Granola Bar packages with UPC Code 85239 20124 and a “Best By” date of 18JAN2010.

The recall was initiated as a precautionary measure after it was discovered that product was mispackaged and the retail units may also contain Peanut Butter Chocolate Chip Bars and S’more Bars. As a result the ingredient statement on the retail package does not include peanuts as an ingredient. People who have allergies to peanuts run the risk of serious or life threatening allergic reactions if they consume this product.

The wrappers of the individual bars within the retail package have correct variety name on it. However, out of an abundance of precaution, the mispackaged product is being recalled.

No illnesses or allergic reactions have been reported to date.

The product is available in 15.2 oz. boxes containing 18 bars per box and the date code is found printed in white on the right side of the box. The “Best By” date of 18JAN2010 is the only date code affected by the recall. This product was distributed in Target stores in 35 states (AK, AL, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, MA, MD, ME, MI, MN, MO, MT, ND, NE, NH, NJ, NV, NY, OH, OR, PA RI, SC, UT, VA, WA WI, WY).

No other Market Pantry products are involved in this recall.

The safety and quality of Leclerc Foods USA, Inc. products are of utmost importance to the company.

Consumers are advised not to consume these items and may return the items to Target for a refund or they may call Target Guest Relations at 1-800-316-6151.

Consumers with additional questions on the recall may contact Leclerc Foods Customer Service at 1-800-463-6144, Monday to Friday between 8:30am and 4:30pm EDT.

This recall is being made with the knowledge of the Food and Drug Administration.

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