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Product Recalls

December 4 – December 31, 2013

This section includes recalls from the Food and Drug Administration (FDA) Enforcement Report for drugs and dietary supplements (www.fda.gov/Safety/Recalls/EnforcementReports/default.htm), and Consumer Product Safety Commission (CPSC) recalls of consumer products.

DRUGS AND DIETARY SUPPLEMENTS

Recalls and Field Corrections: Drugs – CLASS II

Indicates a problem that may cause temporary or reversible health effects; unlikely to cause serious injury or death

Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100-count bottles. Lot #: 59380831, expiration date 05/2014. Volume of product in commerce: 756 bottles. Failed Tablet/Capsule Specifications: Partial tablet erosion resulting in tablet weights below specification in some tablets. Actavis Elizabeth LLC

Carisoprodol Tablets, USP 350 mg, 1,000 tablets. Multiple lots. Contact your pharmacist. Volume of product in commerce: 20,534; bottles. Presence of Foreign Substance: Heavy metals (chromium, titanium, etc.) and inactive components of the product were visually observed during routine stability testing. West-Ward Pharmaceutical Corp.

Diovan (valsartan). Multiple doses, multiple lots affected. Contact your pharmacist. Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.

Exforge (amlodipine and valsartan). Multiple doses, multiple lots affected. Contact your pharmacist. Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide). Multiple doses, multiple lots affected. Contact your pharmacist. Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.

Lescol XL (fluvastatin sodium). Multiple doses, multiple lots affected. Contact your pharmacist. Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.

Stalevo (carbidopa, levodopa, entacapone). Multiple doses, multiple lots affected. Contact your pharmacist. Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.

Tekturna (aliskiren). Multiple doses, multiple lots affected. Contact your pharmacist. Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.

Tekturna HCT (aliskiren and hydrochlorothiazide). Multiple doses, multiple lots affected. Contact your pharmacist. Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.

Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards. Volume of product in commerce: 1,536 cartons. Lot #: 130007, expiration date: 01/31/2014. Subpotent product. American Health Packaging

CONSUMER PRODUCTS

Contact the Consumer Product Safety Commission (CPSC) for specific instructions or return the item to the place of purchase for a refund. For additional information from the CPSC, call its hotline at (800) 638-2772. The CPSC website is www.cpsc.gov. Visit www.recalls.gov for information about FDA recalls and recalls issued by other government agencies.

Name of Product; Problem; Recall Information

Accent Chair. The front legs on the chair can loosen and detach, posing a fall hazard and risk of injury to the consumer. Hobby Lobby Stores at (800) 326-7931 or www.hobbylobby.com.

Aristocrat II Carpet. The carpet fails to meet federal flammability standards, posing a fire hazard to consumers. Shaw Industries at (800) 241-4031 or www.shawfloors.com.

Bristol Valley Cocktail Glasses with Sheer Rim. The glasses can break unexpectedly, posing a laceration hazard. Libbey Glass at (800) 982-7063 or www.libbey.com.

Cabrinha H2 Hydra Series Binding. The binding can detach from its base while riding and lead to loss of control, which poses a risk of injury. E-mail support@cabrinhakites.com.

Candle Ring - Pine Berry. The candle rings’ synthetic foliage and berries are flammable, posing a fire hazard. The Yankee Candle Company, Inc. at (877) 417-2230 or www.Yankeecandle.com.

Children’s Spoon and Fork Sets. The utensil’s handle can detach, posing a choking hazard to infants. Edoche at (774) 295-0170 or www.edoche.com.

Commercial Walk-Behind Mowers. The mower’s blade can break and injure the user and others nearby. Exmark at (800) 667-5296 or www.exmark.com.

Efco brand Gas Trimmers from Emak USA. The muffler on the trimmer’s engine can break during use and pose a fire hazard. Emak USA at (800) 800-4420 or www.efcopower.com.

Girls BCG Hooded Windsuits. The hooded windsuits have drawstrings in the hood around the neck area that pose a strangulation hazard to young children. In February 1996, CPSC issued guidelines about drawstrings in children's upper outerwear. In 1997, those guidelines were incorporated into a voluntary standard. Then, in July 2011, based on the guidelines and voluntary standard, CPSC issued a federal regulation. CPSC's actions demonstrate a commitment to help prevent children from strangling or getting entangled on neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. Academy Sports + Outdoors at (888) 922-2336 or www.academy.com.

Girl’s Long-sleeved Hooded Jacket and Pant Sets. The jackets sold with the set have drawstrings through the hood which pose a strangulation hazard to young children. In February 1996, CPSC issued guidelines for children’s upper outerwear. In 1997, those guidelines were incorporated into a voluntary standard. Then, in July 2011, based on the guidelines and voluntary standard, CPSC issued a federal regulation. CPSC’s actions demonstrate a commitment to help prevent children from strangling or getting entangled on neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. David’s Place Off Price Clothing at (888) 394-1398 or e-mail dania@ymijeans.com.

HP Chromebook 11 Power Supply/Charger. The computer’s charger can overheat and melt, posing fire and burn hazards. Google at (866) 628-1371 or http://chromebook.com.

IQ Girls’ Hooded Pink Leopard Jackets. The jackets have a drawstring through the hood which can pose a strangulation hazard to children. In February 1996, CPSC issued guidelines about drawstrings in children's upper outerwear. In 1997, those guidelines were incorporated into a voluntary standard. Then, in July 2011, based on the guidelines and voluntary standard, CPSC issued a federal regulation. CPSC's actions demonstrate a commitment to help prevent children from strangling or getting entangled on neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. Ram’s Imports at (855) 346-5950 or www.ramsimports.com.

Manhattan Toy® Quixel™ baby rattles. The colored arches can break, creating a small part which poses a choking hazard to small children. Manhattan Group at (800) 541-1345 or www.manhattantoy.com.

Multi-Purpose Yard Vehicles. The mower blades can detach during use or start without being activated by the operator and the vehicle can move forward unexpectedly, posing a laceration hazard. Also, the fuel lines can leak, posing a fire hazard. Denver Global Products at (888) 321-5700 or www.denverglobal.com.

Oodle Swings. The swing seat is suspended too close to the ground, posing an injury hazard to children who can get their legs caught underneath the swing seat. Landscape Structures at (888) 438-6574 or www.playlsi.com.

PackTite™ Heating Units for Bed Bug Control. The bed bug heaters can overheat, melt and cause a fire, posing a fire hazard. PackTite at (866) 520-7952 or www.packtite.com.

Personal Emergency Reporting System (PERS) Transmitters. The battery clips in the transmitters can corrode causing the transmitters to operate intermittently or not at all, without generating a warning. Linear at (855) 554-2384 or www.linear-pers.com.

Playtex Hip Hammock Infant Carriers. The buckles on the waist and shoulder straps can crack or break, posing a fall hazard to the child. Playtex at (800) 522-8230 or www.playtexproducts.com.

Pre-lit Artificial Christmas Trees. The electrical components of the tree’s light strings can overheat and melt, posing fire, burn, and shock hazards to consumers. Seasonal Specialties at (800) 353-3116 or www.seasonalspecialties.com.

Steel Toe Work Boots. The steel toe cap in the boots could fail to protect the wearer’s feet in an impact. Red Wing Shoes at (800) 733-9464 or www.redwingshoes.com.

TimeMaster and TurfMaster lawn mowers. The mower’s blade can break and injure the user and others nearby. Toro toll-free at (855) 340-7686 or www.toro.com.

Total Care, Aerosol Cleaner, Lubricant & Coolant. Vapors from the propellant in the Total Care product can ignite upon contact with hair clippers, posing a burn hazard to consumers. Wahl at (800) 767-9245 or www.wahl.com.

Tornado Brand Home Playground Tube Slides With Port Holes. The plastic port hole-type windows in the tube slide can break, posing a laceration hazard to children. Solowave toll-free at (866) 678-0376 between 9 a.m. and 5 p.m. ET Monday through Friday, or online at www.solowavedesign.com and click on Important Safety Notice for more information.

Trek Model Year 2013 Madone Bicycles. The bicycle’s front brake can fail, posing a crash hazard. Trek at (800) 373-4594 or www.trekbikes.com.

Water-absorbing Polymer Toys. These soft and colorful products can be mistaken by a child for candy. When swallowed, they can expand inside a child’s body and cause intestinal obstructions, resulting in severe discomfort, vomiting, dehydration and could be life threatening. Similar toys have not shown up on x-rays and needed surgery to be removed from the body. Doodlebutt at (239) 313-9779 or e-mail whitmana@live.com.

Yoki Girl’s Faux Leather Jacket. The jackets have a drawstring through the hood which can pose a strangulation hazard to children. In February 1996, CPSC issued guidelines about drawstrings in children's upper outerwear. In 1997, those guidelines were incorporated into a voluntary standard. Then, in July 2011, based on the guidelines and voluntary standard, CPSC issued a federal regulation. CPSC's actions demonstrate a commitment to help prevent children from strangling or getting entangled on neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. Mirage Fashion’s at (855) 221-5888 or e-mail Recalls@yokisport.com.

Zoom Car Seat Adapter. Adapter clips can loosen on the stroller frame, posing a fall hazard. Joovy at (855) 251-0759 or www.joovy.com.

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