Health Letter, March 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
Levothroid (Levothyroxine Sodium Tablets), USP, 50 mcg., 100-count bottles. Volume of product in commerce: 37,441 bottles. Subpotent: nine-month stability interval. Lot #s: 1093992 and 1094095, expiration date 9/2012. Lloyd Inc. of Iowa.
Levothroid (Levothyroxine Sodium Tablets), USP, 75 mcg., 100-count bottles. Volume of product in commerce: 16,548 bottles. Subpotent: nine-month stability interval. Lot #: 1094098, expiration date 9/2012. Lloyd Inc. of Iowa.
Levothyroxine Sodium Tablets, USP, 175 mcg in 90-count bottles. Volume of product in commerce: 7,432 bottles. Subpotent: 15-month stability interval. Lot #: 11T7011A, expiration date 12/2012. Alara Pharmaceutical Co.
Lisinopril Tablets, USP, 40 mg, packaged in: (a) 100-count tablets per bottle; (b) 1,000-count tablets per bottle. Volume of product in commerce: unknown. Presence of foreign substance: Uncharacteristic black spots identified as a food-grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets. Multiple lots affected. West-ward Pharmaceutical Corp.
Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in: (a) 100-count tablets per bottle; (b) 1,000-count tablets per bottle. Volume of product in commerce: 43,478 bottles. Presence of foreign substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets. Multiple lots affected. West-ward Pharmaceutical Corp.
Mylan, Tacrolimus Capsules, 0.5 mg, 100-count bottle. Volume of product in commerce: 15,181 bottles. Failed USP content uniformity requirements: Out-of-specification result reported on retained samples. Lot #s: 3027684, expiration date 5/13; 3027688, expiration date 6/13; and 2002157, expiration date 9/12. Mylan LLC.
Prednisone Tablets, USP, 10 mg. Volume of product in commerce: 86,616 bottles. Presence of foreign substance(s): Sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions. Multiple lots affected. L. Perrigo Co.
Prednisone Tablets, USP, 20 mg, packaged in: (a) 100-count tablets per bottle; (b) 500-count tablets per bottle; and (c) 1,000-count tablets per bottle. Volume of product in commerce: 60,289 bottles. Presence of foreign substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions. Multiple lots affected. West-ward Pharmaceutical Corp.
Propylthiouracil Tablets, USP, 50 mg, packaged in: (a) 100-count tablets per bottle; (b) 1,000-count tablets per bottle. Volume of product in commerce: 43,075 bottles. Presence of foreign substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets. Lot #s: 68478A, 69059A, 69059B, expiration date 1/16. Westward Pharmaceutical Corp.
Synthroid (Levothyroxine Sodium) Tablets, 150 mcg (0.15 mg), 90 tablets per bottle. Volume of product in commerce: 28,524 bottles. Labeling: Error on declared strength. Product labeled to contain 150-mcg tablets actually contained 75-mcg tablets. Lot #: 18262A8, expiration date 09/13. Abbott Laboratories.
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
2013 Polaris Ranger® 400 Recreational Off-Highway Vehicles. The recreational vehicle’s throttle can fail to operate properly, which can cause the vehicle’s rider to lose control, posing a crash hazard. Polaris, at (888) 704-5290 or www.polarisindustries.com.
Air Mister. The Air Mister can shatter during use, posing an injury hazard. Target, at (800) 440-0680 or www.target.com.
Amana Packaged Gas/Electric Heating and Cooling Units. The serial plates on the units have inaccurate information that could result in installers and servicers using undersized wiring, posing a fire hazard. Goodman, at (800) 394-8084 or www.amana-hac.com.
Bicycles and Frame Sets. The steerer tube in the front fork can break, posing a fall hazard. Specialized Bicycle Components, at (877) 808-8154 or www.specialized.com.
Bugaboo Cameleon and Bugaboo Donkey Model Strollers. A button on the stroller’s carrycot/seat carry handle can become disengaged and cause the handle to detach, posing fall and choking hazards to young children. Bugaboo International, at (800) 460-2922 or www.bugaboo.com.
Bunk Beds. The openings between the metal rails of the end structures are greater than allowed in the standards and pose a risk of entrapment or asphyxiation hazard. World Imports, at (855) 473-9992 or www.worldimportsltd.com.
Burien Floor Lamps. The on/off foot switch on the lamps can fail and melt, resulting in shock and fire hazards. Dolan NW LLC, at (888) 213-5758 or seattlelighting.com, globelighting.com, builderslighting.com or destinationlighting.com.
Can-Am® Commander Side-by-side Off-road Vehicles. Debris such as leaves, hay and grass in wet-terrain areas can collect in the vehicle’s exhaust pipe area in a short period of time. A hot exhaust pipe and accumulated debris that has dried poses a risk of fire. Also, improper assembly of the steering column to the rack and pinion can result in the loss of steering control, posing a risk of serious injury or death to the user, passenger or bystanders. BRP, at (888) 638-5397 or www.can-am.brp.com.
Children’s Two-piece Pajama Sets. The children’s cotton or cotton/fleece pajamas sets fail to meet the federal flammability standards for children’s sleepwear because they do not meet the tight-fitting sizing requirements. This poses a burn hazard to children. Target, at (800) 440-0680 or www.target.com.
Egg Incubator. The base can ignite during use, posing a fire hazard to the consumer. Brower Division of Hawkeye Steel Products Inc., at www.hawkeyesteel.com.
Enduro Motorcycles. During use, the pre-formed fuel hose can develop small holes or cracks at the ends of the hose, allowing fuel to leak. This poses a fire and crash hazard to the rider and/or others. KTM North America Inc., at (888) 985-6090 or www.ktmusa.com.
Game Winner® Crossbow Cocking Ropes. The hooks attaching the cocking rope to the crossbow string can break and cause it to recoil, posing a laceration hazard. Academy Sports + Outdoors, at (888) 922-2336 or www.academy.com.
Girls’ Circo Fleece Blanket Sleepers. These fail to meet the federal flammability standards for children’s sleepwear, posing a risk of burn injuries.Target, at (800) 440-0680 or www.target.com.
High-Pressure Scuba Diving Air Hoses. The diving hose that connects the regulator to the tank’s pressure gauge can separate, reducing the available air supply to the diver and posing a drowning hazard. A-Plus Marine, at (800) 352-2360 or www.aplusmarine.com.
Magnet Balls® Manipulative Magnet Sets. When two or more magnets are swallowed, they can link together inside a child’s intestines and clamp onto body tissues, causing intestinal obstructions, perforations, sepsis and death. Internal injury from magnets can pose serious lifelong health effects. SCS Direct, at (888) 749-1387.
Mattresses and Mattresses with Foundations. The mattresses fail to meet the mandatory federal open flame standard for mattresses, posing a fire hazard. The Mattress Cloud Inc., at (855) 622-4233.
MegaFood One Daily Supplement Bottles. The packaging is not child-resistant as required by the Poison Prevention Packaging Act. The supplement tablets inside the bottle contain iron, which can cause serious injury or death to young children if multiple tablets are ingested at once. FoodState d/b/a MegaFood, at (866) 234-2668 or www.megafood.com.
Men’s and Women’s Heated Jackets. The heated inner wrist cuff can overheat, posing a burn hazard. Columbia Sportswear Company, at (866) 201-9073 or www.columbia.com.
Million Dollar Baby Dressers. If a young child climbs up open dresser drawers, the dresser can tip over and pose the risk of entrapment. Million Dollar Baby, (888) 673-6652 or www.themdbfamily.com/safety2.
Nanospheres Magnetic Desk Toys. If two or more magnets are swallowed, they can link together inside a child’s intestines and clamp onto body tissues, causing intestinal obstructions, perforations, sepsis and death. Internal injury from magnets can pose serious lifelong health effects. Kringles Toys and Gifts, at (888) 801-1649 or www.kringlestoysandgifts.com.
Natart Chelsea Dressers. If a young child climbs up open dresser drawers, the dresser can tip over and pose the risk of entrapment. Gemme Juvenile, at (855) 364-2619 or www.chelseawallanchors.com.
Newborn Rock ‘n Play Sleeper™. Mold can develop between the removable seat cushion and the hard plastic frame of the sleeper when it remains wet/moist or is infrequently cleaned, posing a risk of exposure to mold to infants sleeping in the product. The CPSC advises that mold has been associated with respiratory illnesses and other infections. Although mold is not present at the time of purchase, mold growth can occur after use of the product. Fisher-Price, at (800) 432-5437 or www.service.mattel.com.
Omni-Heat™ Lithium-Polymer Rechargeable Batteries. The batteries have a cell defect that can cause overheating, posing a fire hazard. Columbia Sportswear Company, at (800) 622-6953 or
Perfect Resistance Bands. The bands can detach from the mesh cloth loops, posing an injury hazard to the user and those in the vicinity. Implus Footcare, at (800) 446-7587 or www.perfectonline.com/recalls.
Q-Series Temperature and Humidity Sensors. The sensors can overheat, posing a fire hazard. Siemens, at (800) 516-9964 or w3.usa.siemens.com/buildingtechnologies.
Reclining Chair. The chair can tip over backwards when used in its fully reclined position, posing a fall hazard to consumers. American Signature Inc., at (800) 743-4577 or www.vcf.com or www.asfurniture.com.
Royal Prestige 9-Ply Thermal Wall Cookware. The cookware can collapse, crimp or severely deform when exposed to heat, posing a burn and fire hazard to the consumer and nearby property. Hy Cite Enterprises, at (800) 609-9577 or www.royalprestige.com.
Sportspower BouncePro 14’ Trampolines. The enclosure netting surrounding these trampolines can break, allowing children to fall through the netting and be injured. Sportspower, at (888) or www.sportspowerltd.net.
Triaminic® Syrups and Theraflu Warming Relief® Syrups. The child-resistant caps can fail to function properly and enable the cap to be removed by a child with the tamper-evident seal in place, posing a risk of unintentional ingestion and poisoning. These products contain acetaminophen and diphenhydramine which are required by the Poison Prevention Packaging Act to be sealed with child-resistant packaging. Novartis Consumer Healthcare, at (866) 553-6742 or www.novartisOTC.com.
Utility Vehicles. The fuel line can separate, posing a fire hazard. Deere and Company, at (800) 537-8233 or www.johndeere.com.
Weight Workbenches. The weld on the backrest adjustment brackets of the weight workbench can break, posing an injury hazard to consumers. Powertec, at (877) 525-5710 or www.PowertecFitness.com.