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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Obama Administration Launches Food Safety Working

New Web Site, www.foodsafetyworkinggroup.gov, Will Serve as Hub for Citizens and Stakeholders to Stay Informed and Provide Input

Responding to President Obama’s directive to upgrade the nation’s food safety system, the White House Food Safety Working Group, led by Agriculture Secretary Tom Vilsack and Health and Human Services Secretary Kathleen Sebelius, launched a Web site to provide information about the group’s activities and progress.

“The Working Group will be an important tool for gathering ideas as to how we can strengthen the food safety system to be more accountable and accessible to the public it protects, flexible enough to quickly resolve new safety challenges that emerge, and able to meet the robust needs of our rapidly changing world,” said Vilsack.

“Families have enough to worry about. You shouldn’t have to wonder if the food you buy at the grocery store is safe,” said Sebelius. “Our Working Group is working hard to modernize our food safety system and protect the American people. The Web site will help ensure all Americans can share their thoughts and contribute to this important process.”

The Web site, www.foodsafetyworkinggroup.gov will be an important resource for people who want to stay apprised of the Working Group’s progress, learn about food safety tools and practices, and share their views on how to improve the food safety system. The Web site features social bookmarking tools including an RSS feed and a widget that can be downloaded to help individuals stay informed.

Last week, representatives from the White House Food Safety Working Group met and outlined principles to meet the President’s goal. In the weeks to come, the Food Safety Working Group will provide additional opportunities to engage stakeholders in conversations and help shape these principles.

A comprehensive approach to an improved national food safety system links statutory modernization to regulatory actions and public health outcomes. The public health approach that serves as the basis of the Working Group’s efforts focuses resources according to risk, applies the best available science and high quality data to the decision-making process, and strives for seamless coordination among federal agencies and their state, local and international public health partners.
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Dietary Supplements Worth $1.3 Million Condemned and Forfeited to the United States

Under Consent Decree FDA alleged ‘Body-building’ products contained unapproved food additive, new dietary ingredient and these products will now be destroyed

The U.S. District Court for the Eastern District of Michigan, Southern Division, today entered a consent decree that condemns and forfeits to the United States for destruction about $1.3 million worth of dietary supplements.

“The court order is the result of efforts by the federal government to protect consumers from products for which there is inadequate information to assure that they do not present a significant or unreasonable risk of illness or injury,” said Michael Chappell, FDA’s acting associate commissioner for regulatory affairs. “It shows that the agency is prepared to use the necessary legal means to keep such products out of the marketplace.”

At the request of the FDA, U.S. Marshals seized more than 23,300 bottles of three dietary supplement products distributed by LG Sciences LLC, of Brighton, Mich. The seized products were marketed for use by body builders and distributed on the Internet and in retail stores under the names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL.”

Based on laboratory tests, the FDA determined that the products contain one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to assure that the ingredients do not present a significant or unreasonable risk of illness or injury. Specifically, the condemned Methyl 1-D and Methyl 1-D XL contained 1,4,6-androstatriene-3,17-dione, also known as “ATD” or 1,4,6-etioallocholan-dione. The condemned Formadrol Extreme XL contained ATD and 3,6,17-androstenetrione (also known as “6-OXO”). Both of these substances are steroids that inhibit the activity of the enzyme aromatase and may be found in dietary supplements promoted to boost testosterone levels.

The FDA has no scientific information concerning the safety of the condemned products or their ingredients and, thus, cannot determine whether they represent a hazard to consumers. Under the circumstances, consumers who use or have used the products should discuss their use with their health care professionals.

The FDA also recommends that consumers consult their health care professionals if they have experienced any adverse events that they suspect are related to the products’ use.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
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Stonyfield Farm Recalls Some Quarts of Plain Yogurt

Stonyfield Farm, Londonderry, New Hampshire, is recalling some Fat Free Plain Yogurt Quarts in Stonyfield Farm branded containers. The products are being recalled because they may contain a presence of food grade sanitizer.

Recalled products are limited to Stonyfield Farm 32-ounce Fat Free Plain yogurt UPC # 52159 00006 carrying one of the following product codes printed along the cup bottom that start with the following date codes:

May 06 09 Time stamped 22:17 thru 23:59 (limited to these specific time stamps only)
May 07 09 All time stamps

Approximately 44,000 quarts were distributed to retail accounts nationally.

Consumers are advised not to consume the product and to return opened and unopened containers to the store where it was purchased. Anyone returning these products will be reimbursed for the full value of their purchase.

Customers with questions should contact Stonyfield Farm Consumer Relations at 1-800-Pro-Cows (776-2697) or visit the company’s website at www.stonyfield.com.

“Our sanitarians will be checking store shelves as part of their routine inspections to make sure any recalled items are removed from sale,” said Georgia Agriculture Commissioner Tommy Irvin.
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QFCO, Inc. Recalls White Rabbit Candy Because of Possible Health Risk

QFCO, Inc. of Burlingame, California is recalling White Rabbit Candy because it may be contaminated with Melamine.

Product was distributed to the states of CA, GA, HI, IL, MN, NY, OR, TX, WA through wholesale distributors to retail stores.

The White Rabbit Creamy Candy is sold in 8 or 16 oz packages. All other flavors of White Rabbit Candy, including Assorted (Chocolate, Coconut, and Coffee), Red Bean, Coffee, Corn, Lychee, Mango and Strawberry are sold in 7 oz. packages. All packaging has a logo of a white rabbit on the front with the words "White Rabbit".

No illnesses associated with this product have been reported to date.

The recall was initiated after it was discovered that product was contaminated with Melamine.

Consumers who have purchased White Rabbit Candy are urged to return it to the place of purchase for a full refund or discard it in their trash. Consumers with questions may contact the company at (650) 697-6633.

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Wooden Infant Toys Recalled by Habermaass Corp. Due to Choking Hazard

Name of Product: Wooden Puzzles, Infant Rattles, Pacifier Holders, and Stroller Toys

Units: About 118,000

Manufacturer: Habermaass Corp. Inc., of Skaneateles, N.Y.

Hazard: The wooden rattles, pacifier holders, and stroller toys contain small pieces including glued on mirrors and/or prisms that can detach, posing a choking hazard to infants. The head of the ladybug puzzle pieces also poses a choking hazard.

Incidents/Injuries: Habermaass Corp. has received 15 reports of incidents involving the recalled puzzles, rattles, and pacifier holders including pieces of the rattles detaching and being mouthed by young children.

Description: The puzzles, rattle toys, pacifier holders, and stroller toys are wooden and are described in the chart below. “HABA” is printed on them.

Sold at: Specialty toy stores nationwide and at specialty online retailers from January 2002 through August 2008 for between $10 and $35.

Manufactured in: Germany

Remedy: Consumers should immediately take the recalled puzzles, rattles, pacifier holders and stroller toys away from children and contact Habermaass to receive a free replacement product or a full refund.

Consumer Contact: For additional information, contact Habermaass Corp. at (800) 468-6873 ext. 107 between 8 a.m. and 5 p.m. ET Monday through Friday, or visit the firm’s Web site at www.HABAusa.com/safety

Model: Description
Triolino Puzzle: Lady bug puzzle is 7 inches x ½ inch thick
LUCY Clutching Toy (rattle): Hearts have mirrors and prisms. The rattle is about 4 inches in diameter.
Little Heart Clutching Toy (rattle): Heart has mirror. The rattle is about 3 ½ inches in diameter.
Pixie’s World (rattle): 2.5” rattle with mushroom, flower, person and house with mirror.
Belinda Clutching Toy (rattle): Flower clutching toy has face in the middle. The rattle is about 4 inches in diameter.
Miro Clutching Toy (rattle): Rattle center contains blue plastic ball with 10 holes. The rattle is about 3 ½ inches in diameter.
Bunny Pacifier Holder: Pacifier holder is 8.6 inches long with fabric bunny on the end and wooden star with mirror in the middle.
Bear Pacifier Holder: Pacifier holder is 8.6 inches long with bear at the end and wooden circle with mirror in the middle.
Bonita (rattle): 2.5” bouquet of four shapes on wooden ring.
Bella (rattle): 3” diameter with four wooden hearts with two mirrors.
Pirate Joe (rattle): 4” pirate theme with bell and mirror.
Rally (rattle): 4” triangle shape with three cars.
Flori (rattle): Six petal shapes on elastic band. Includes three mirrors & three bells. 5”Triola (rattle): 4” triangle with two flowers and round corner.
Trio (rattle): 4” triangle shape with squeaker, bell and mirror.Speedy (rattle): Wooden car about 4.5” L x 3” H. Squeaker in back and mirror on car hood.
Little Hearts Stroller Toy: 18” pram-chain with ten various size wooden hearts.
Discovery Balls, Set of 4: Set contains 1 orange, 1 red, 1 blue and one bicolor blue/yellow ball. Red ball contains three small mirrors.
Discovery Ball with Rattle: Blue/Yellow round wooden ball with small mirror.
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Children's Hooded Sweatshirts and Jackets with Drawstrings Recalled by Orioxi International Due to Strangulation Hazard

Name of Product: Children’s Hooded Sweatshirts and Jackets
Units: About 43,000
Importer: Orioxi International Corp., of Brea, Calif.
Hazard: The sweatshirts and jackets have drawstrings through the hood which pose a strangulation hazard to young children. In February 1996, CPSC issued guidelines to help prevent children from strangling or getting entangled on the neck and waist drawstring in upper garments, such as jackets and sweatshirts.
Incidents/Injuries: None reported.
Description: The recalled garments were sold in children’s sizes small, medium and large in the following colors: white, ivory, red, black, navy, brown, green, charcoal, blue, and pink. “BAC” is printed on the sewn-in tag on some of the garments. “Breckenridge”, “Keystone”, “Jackson Hole”, “Vail”, “Steamboat”, and “Mackinac Island” is printed on the front of the garments.
Sold at: “Shirt off My Back” retail stores located in Colorado, Wyoming, and Michigan from September 2005 through May 2008 for between $20 and $30.

Manufactured in: China

Remedy: Consumers should immediately remove the drawstrings from the sweatshirts to eliminate the hazard. Consumer can return the garments to the place of purchase for a refund.

Consumer Contact: For additional information, contact Outfitter Trading Company at (800) 875-4352 between 9 a.m. and 5 p.m. MT Monday through Friday or visit the firm’s Web site at www.shirtoffmyback.com
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Regal Lager Recalls to Repair Phil & Teds Strollers Due to Laceration Hazard

Name of Product: Phil & Teds e3 Single Buggy, e3 Twin Buggy and sport v1 Single Buggy Strollers (an additional 425 e3 Twin Buggy Strollers were recalled on May 5, 2006)

Units: About 44,000

Importer: Regal Lager Inc., of Kennesaw, Ga.

Hazard: The stroller’s hinge locking mechanism poses a laceration hazard to the user folding and unfolding the strollers.

Incidents/Injuries: Regal Lager has received nine reports from consumers who injured their fingers in the stroller’s hinge locking mechanism.

Description: The recalled single strollers all have metal frames with three wheels, a cloth seat and canopy. The twin strollers have a metal frame with four wheels, side-by-side cloth seats and double sun canopies. The strollers were sold in a variety of colors including red, orange, green, black, charcoal and navy. The Phil & Teds logo is located on the crotch piece of the harness.

Sold at: Baby furniture and baby products stores nationwide from August 2003 through August 2008 for between $400 and $650.

Manufactured in: China

Remedy: Consumers should stop using the strollers immediately and contact Regal Lager to obtain a free hinge cover repair kit and instructions.

Consumer Contact: For more information, consumers can Regal Lager toll-free at (877) 242-5676 between 9 a.m. and 5 p.m. ET Monday through Friday or visit the firm’s Web site at www.regallager.com
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Countertop Water Dispensers Recalled by Greenway Home Products Due to Fire and Shock Hazards

Name of Product: Countertop Water Dispensers
Units: About 44,000
Manufacturer: Greenway Home Products, of Northwood, Ohio
Hazard: The internal heating element could overheat and drop molten metal through ventilation openings in the water dispenser’s base onto the countertop, posing a fire hazard. The internal heating element also poses a shock hazard to consumers who touch it through the vents.
Incidents/Injuries: Greenway has received one report of a fire involving the recalled countertop water dispenser outside the United States that resulted in property damage. No injuries have been reported.
Description: The recalled countertop water dispensers include the following Vitapur, Greenway and Polar models. They dispense hot or cold water and use three or five gallon water bottles. The model name is printed on the front of the dispenser’s base. Model and serial numbers are printed on a white label on the back of the dispenser’s base. File number 218326 is printed on a silver sticker on the back of the dispenser’s base.

Models:
Greenway GWD2630W
Polar PWD2635W
Vitapur VWD2636W
Vitapur VWD2636BLK
Vitapur VWD2636RED

Serial Number: Starts with 0606 through 0711
File Number: 218326 Model numbers followed by a “1” or “2,” (i.e. GWD2630W -1 / PWD2635W-2), or dispensers with no ventilation openings underneath the base are not included in this recall.
Sold at: Discount retailers nationwide from June 2006 to November 2007 for between $70 and $80.

Manufactured in: China

Remedy: Consumers should stop using the recalled water dispensers immediately and contact Greenway Home Products to receive a free repair.
Consumer Contact: For additional information, contact Greenway Home Products toll-free at (866) 279-0088 between 9 a.m. and 4 p.m. ET Monday through Friday, or visit the firm’s Web site at www.greenwayhp.com
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Six Retailers Agree To Stop Sale and Recall Simplicity Bassinets Due To Strangulation Hazard

The U.S. Consumer Product Safety Commission (CPSC) is urging retailers across the country to protect the health and safety of babies by stopping sale and recalling nearly 900,000 dangerous Simplicity bassinets.

Yesterday, CPSC warned parents, caregivers and consumers to immediately stop using convertible "close-sleeper/bedside sleeper" bassinets manufactured by Simplicity Inc., of Reading, Pa., due to a serious safety risk. Today, CPSC is announcing that the following retailers have voluntarily agreed to recall the product and provide a refund or store credit to consumers who return the product to the store where purchased:

Wal-Mart Stores Inc., of Bentonville, Ark. – (800) 925-6278 or http://www.walmart.com/
Toys "R" Us Inc., of Wayne, N.J. - (800) 869-7787 or www.toysrus.com or http://www.babiesrus.com/
Kmart Corp., of Hoffman Estates, Ill. – (800) 659-7026 or http://www.kmart.com/
Big Lots!, of Columbus, Ohio – (866) 244-5687 or http://www.biglots.com/
Target of Minneapolis, Minnesota sold at http://www.target.com/ only
J.C. Penney, of Plano, Texas – (888) 333-6063 or http://www.jcp.com/

Below is a listing of Simplicity 3-in-1 and 4-in-1 Convertible "Close-Sleeper" model bassinets that are included in this recall. The model number can be found on a label on the underside of the bassinet. RECALLED Model Numbers:

3000CL
3112DOH6
3011WHE
9250A
3016LAU
3046GTM
3010BIJ
3112DOH
73011WHK
3012SOM
3016MIR
3046HAN
3010HAV
3122BAN
3012BIJ
5750SAR
3017NCB
3047MON
3010NGS
3122TGC
3012OXF
3012TGT
3020SFB
3050LIL
3010TGT
3010BIJC
3012SFD
3013PRO
3025BER
3050SAR
3010WHE
343-8363
3040SAR
9250B
3025C
3060GFS
3040LAU
343-8399
3040SPR
3014LOL
3026CRT
3060TFS
TD2500
3045FEL
3050SWT
3014NGS
3027MIS
8393
3040WDS
3111DPC
3060BTL
3015GFR
3030SAR
3040SPRC
3045DRM
3012LLTC
3112BDY
3070MAN
3040CLA
3040LAC
3111ZOL
3050SWTC
3045OXFC
3112DOH
5730FKB
3045DRMC

CPSC learned that on August 21, 2008, a 6 ½-month-old girl from Shawnee, Kan. was strangled to death when she became entrapped between the bassinet’s metal bars. This is the second strangulation death CPSC has learned of in the co-sleeper bassinets. On September 29, 2007, a 4-month-old girl from Noel, Mo. became entrapped in the metal bars of the bassinet and died.

The Simplicity 3-in-1 and 4-in-1 convertible bassinets contain metal bars that are covered by an adjustable fabric flap which is attached by velcro. The fabric is folded down when the bassinet is converted into a bed-side co-sleeping position. If the velcro is not properly re-secured when the flap is adjusted, an infant can slip through the opening and become entrapped in the metal bars and suffocate. This warning does not cover bassinets produced in recent months that have fabric permanently attached over the lower bar.

Due to the serious hazard these bassinets pose to babies, CPSC urges all consumers to share this safety warning with day care centers, consignment stores, family and friends to ensure that no child is placed to sleep in a Simplicity convertible bassinet covered by this warning. To see this release on CPSC's web site, including pictures of the recalled product, please go to: http://www.cpsc.gov/cpscpub/prerel/prhtml08/08381.html
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Infants Strangled to Death in Simplicity Bassinets: CPSC Urges Consumers To Stop Using Simplicity 3-in-1 and 4-in-1 Convertible “Close-Sleeper” Models

The U.S. Consumer Product Safety Commission (CPSC) is urging parents and caregivers to stop using convertible “close-sleeper/bedside sleeper” bassinets manufactured by Simplicity Inc., of Reading, Pa.

CPSC has learned that on August 21, 2008, a 5-month-old girl from Shawnee, Kan. was strangled to death when she became entrapped between the bassinet’s metal bars. This is the second strangulation death CPSC has learned of in the co-sleeper bassinets.

On September 29, 2007, a 4-month-old girl from Noel, Mo. became entrapped in the metal bars of the bassinet and died.

CPSC is issuing this safety alert because SFCA Inc., the company which purchased all of Simplicity Inc.’s assets at public auction in April 2008, has refused to cooperate with the government and recall the products. SFCA maintains that it is not responsible for products previously manufactured by Simplicity Inc.

The Simplicity 3-in-1 and 4-in-1 convertible bassinets contain metal bars spaced farther apart than 2 3/8 inches, which is the maximum distance allowed under the federal crib safety standard. The metal bars are covered by an adjustable fabric flap which is attached by velcro. The fabric is folded down when the bassinet is converted into a bed-side co-sleeping position. If the velcro is not properly re-secured when the flap is adjusted, an infant can slip through the opening and become entrapped in the metal bars and suffocate.

This warning does not cover bassinets produced in recent months that have fabric permanently attached over the lower bar.

Due to the serious hazard these bassinets pose to babies, CPSC urges all consumers to share this safety warning with day care centers, consignment stores, family and friends to ensure that no child is placed to sleep in a Simplicity convertible bassinet covered by this warning.

The Commission voted, using its new authorities in the Consumer Product Safety Improvement Act, to release this warning upon making a finding that the health and safety of the public require immediate notice.

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Bonne Bell Recalls Children's Cosmetics Accessory Bags Due to Risk of Lead Exposure

Name of Product: Bonne Bell Children’s Cosmetics Accessory Bags

Units: About 945,000

Importer: Bonne Bell Co., of Lakewood, Ohio

Hazard: The metal clasps on the handle of the accessory bags contain excessive levels of lead, which is toxic if ingested and can cause adverse health effects.

Incidents/Injuries: None reported.

Description: The recalled accessory bags are made of plastic and have a zipper and carrying handle. The bags come with an assortment of cosmetic products, which are not part of this recall. The model name and UPC numbers are located on the hangtag. The following recalled model names and UPC numbers are involved in this recall:

SMACKERS Sweet Treats Collection UPC 0 50051 50575 7
SMACKERS Sparkle & Shine Collection UPC 0 50051 50576 4
SMACKERS Glam It Up Collection UPC 0 50051 50577 1
BONNEBELL Natural Neutrals Collection UPC 0 50051 22640 9
BONNEBELL Pretty Pinks Collection UPC 0 50051 22641 6
BONNEBELL Fresh Pinks Collection UPC 0 50051 22642 3
BONNEBELL Glamorous Neutrals Collection UPC 0 50051 22643 0

Sold at: Retail stores nationwide and Bonne Bell’s Web site from September 2007 through August 2008 for about $9.

Manufactured in: China

Remedy: Consumers should immediately take the recalled accessory bag away from children and contact Bonne Bell for a replacement bag.

Consumer Contact: For more information, consumers can contact Bonne Bell toll-free at (866) 288-8643 between 9 a.m. and 5 p.m. ET Monday through Friday, or via email at quality@bonnebell.com, or visit the company’s Web site at www.thebonnebellcompany.com/recall/
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"Fresh from the Deli" American Sub Sandwich Recalled by Landshire, Inc. Because of Possible Health Risk

Landshire, Inc. is recalling its American Sub sandwich because it has the potential to be contaminated with Listeria Monocytogenes, 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 stillbirths among pregnant women.

The American Sub sandwiches were distributed in the Midwestern States of: Indiana, Kentucky, Ohio and Pennsylvania. The product was sold to Circle K Convenience Stores exclusively. There were 812 sandwiches produced on lot number 21882.

The sandwich label identifies it as: "Fresh from the Deli" American Sub. This is a pre-packaged, individually wrapped (clear plastic) with a black tray inside of package. Sandwich weight is 9.75ounces (276grams). UPC code is 9748800540. The sandwiches involved have a lot number of 21882. The lot number is printed in black ink on the side of the package.

No illnesses have been reported to date.

The recall was the result of a routine sampling taken by the Ohio Department of Agriculture for retail food establishments. Landshire has ceased the production and distribution of the product as the Company continues its investigation as to the source of the problem.

Consumers who have purchased the "Fresh from the Deli" American Sub are urged to return it to the place of purchase for a full refund. Consumers with questions may contact Landshire, Inc at 800-468-3354.
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Trans Ocean Products Recalls "Cracked Pepper Style Smoked Salmon" LOT No 54933-2 Because of Possible Health Risks

Trans-Ocean Products, Inc. of Bellingham, Washington is recalling its 4 ounce Cracked Pepper Style Smoked Salmon Lot No 54933-2 because it has the potential to be contaminated with Listeria monocytogenes, 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 stillbirths among pregnant women.

Cracked Pepper Style Smoked Salmon, 4 ounce packages were distributed to three supermarket chains in seven states: Brookshire Brothers in Texas and Louisiana; Price Choppers in New York, Pennsylvania, Massachusetts and Vermont; and Giant Eagle in Ohio and Pennsylvania.

The product is sliced cold-smoked salmon with black pepper. It is vacuum packaged in a resealable purple plastic pouch and bears the brand name Trans Ocean Products.The lot number is ink jetted on the back panel of the package, just right of center.

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

The potential for contamination was noted after routine testing by Trans-Ocean Products revealed the presence of Listeria monocytogenes in one 4 ounce package of Cracked Pepper Style Smoked Salmon.

Distribution of the product has been suspended while the FDA and Trans-Ocean Products investigate the source of the problem.

Consumers that have purchased Trans Ocean ProductsCracked Pepper Style Smoked Salmon are urged to return them to the place of purchase for a full refund.

Consumers with questions may contact Trans-Ocean Products. Call (800) 290-2722 Monday – Friday 6AM to 5PM. Over the Labor Day weekend call (360) 739-4181.
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