Health Letter, January 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 I
Indicates a problem that may cause serious injury or death
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg, 100-count bottle. Volume of product in commerce: 14,445 bottles. Superpotent (multiple ingredient) drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. Lot #: C1440512A, expiration date 12/2013. Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg, 500-count tablets per bottle. Volume of product in commerce: 4,874 bottles. Lot #s: 519406A, 521759A, expiration date 4/2014. Watson Laboratories, Inc.
X-ROCK 3-Day Pill for Men, 1- and 2-capsule blister packs and 6-, 12- and 24-count bottles. Volume of product in commerce: unknown. Marketed without an approved NDA/ANDA: Product tested positive for sildenafil and analogs of sildenafil. Lot #s: All lots, all codes. Manufactured by CRM Laboratories, distributed by XRock Industries.
X-ROCK for Men, Dietary Supplement Capsules. Volume of product in commerce: 215,000 capsules. Marketed without an approved NDA/ANDA: Product tested positive for PDE-5 sildenafil and PDE-5 hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA-approved prescription drug for erectile dysfunction (ED). Lot #s: All lots with UPC 0 00309 50792 7. Manufactured by CRM Laboratories, distributed by XRock Industries.
Z-ROCK All-Natural Male Supplement, 1-capsule blister pack. Volume of product in commerce: unknown. Marketed without an approved NDA/ANDA: Products tested positive for sildenafil and analogs of sildenafil. Lot #s: All lots, all codes. Distributed by Zrock USA.
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
All Sterile Products Manufactured by NECC (New England Compounding Center). Volume of product in commerce: unknown. Lack of assurance of sterility, GMP deviations. Lot #s: All lots, all codes. A complete list of products can be found on its website at www.neccrx.com.
All Sterile Products Manufactured by Ameridose LLC. Volume of product in commerce: unknown. Lack of assurance of sterility, GMP deficiencies. Lot #s: All lots codes within expiry. A complete list of all products subject to this recall can be accessed online at www.ameridose.com.
Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle. Volume of product in commerce: 32,208 bottles. Adulterated presence of foreign tablets: A product complaint was received by a pharmacist who discovered an atorvastatin 20 mg tablet inside a sealed bottle of 90-count atorvastatin 10 mg. Lot #: 2407258, expiration date 05/2014. Ranbaxy Inc.
Dr. Reddy’s Quetiapine Fumarate Tablets, 25 mg, 500 tablets. Volume of product in commerce: 1,512 bottles. Failed USP dissolution test requirements: During analysis of long-term stability studies at 3 months time point, an OOS was reported for quetiapine fumarate tablets, 25 mg. Lot #: C203090, expiration date 03/2014. Dr. Reddy’s Laboratories Limited.
Northstar Zolpidem Tartrate Tablets, USP 10 mg. Volume of product in commerce: 23,616 bottles. Adulterated presence of foreign tablets: 30 valacyclovir hydrochloride tablets, USP 500 mg, were discovered in a bottle labeled Zolpidem Tartrate tablets, USP 10 mg. Batch #: ZPSB11054-A, expiration date 05/2013. Manufactured by Aurobindo Pharma Limited.
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 Diamondback Steilacoom RCX Bicycles. Bicycles assembled with incorrect headset parts could cause the steerer tube to fail, causing the rider to lose control and fall or crash. Diamondback Bicycles, at (800) 222-5527 or www.diamondback.com.
Ceiling-Mounted Light Fixture. The fixture’s socket wire insulation can degrade, leading to charged wires becoming exposed, causing electricity to pass to the metal canopy of the fixture. This poses a fire and electric shock hazard to consumers. Dolan Northwest LLC, at (888) 213-5758 or www.seattlelighting.com, www.globelighting.com, www.builderslighting.com or www.destinationlighting.com.
Children’s Pajamas. The pajamas fail to meet federal flammability standards for children’s sleepwear, posing a risk of burn injuries to children. J.P. Boden Services Inc., at (866) 206-9508 or www.bodenusa.com.
Children’s Riding Toy. Children who lean too far forward on the seat can go over the handle bar and hit the ground. This poses a fall hazard. Step2, at (866) 860-1887 or www.step2.com.
Cordless Drill. The black trigger switch on the 19.2v cordless drill can overheat, posing a fire and burn hazard to consumers. Harbor Freight Tools, at (800) 444-3353 or www.harborfreight.com.
Custom Cellular and Pleated Window Coverings. Some of the cords inside the breakaway cord stop were tied in a single knot, which can prevent the cord stop from functioning as designed to break away. A child can become entangled in a cord loop and strangle. Hunter Douglas, at (800) 997-2389 or http://www.hunterdouglas.com/connector.
Dual-Voltage CineMate II Home Theater Speaker Systems. A component in the bass module can fail when used outside of the U.S. in electrical outlets rated at 220 volts or higher, presenting a fire hazard to consumers. Bose Corporation, at (877) 354-1004 or www.bose.com/safety.
Foam Pumpkin Turkey Craft Kit. Magnets holding the pumpkin shell pieces together can become loose, posing an ingestion hazard to young children. If swallowed, these magnets 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. Jo-Ann Fabric and Craft Stores, at (888) 739-4120 or www.joann.com.
Folding Camping Chairs. Chairs were found to contain a variety of molds that could cause respiratory or other infections in individuals with chronic health problems or who have impaired immune systems. Rec-Out, at (888) 885-9129 or e-mail firstname.lastname@example.org.
Fuel Filters and Tune-Up Kits with Fuel Filters. The fuel filter can leak, posing a fire hazard. Kawasaki Motors, at (866) 836-4463 or www.kawpower.com.
Girl’s Pajamas. The pajamas fail to meet federal flammability standards for children’s sleepwear, posing a risk of burn injuries to children. Elephantito, at (888) 776-9541 or www.elephantito.com.
Graco®-branded Avalon Glider Rockers with Ottoman and Complete Nursery Solution (CNS) Box 2 / Katelyn Nursery Solution Glider Rockers. The base of the glider rocker can crack or break, posing a fall hazard. LaJobi, at (888) 266-2848 or www.lajobi.com.
Gruga Office Chairs. The seat plate can break, posing a fall hazard to consumers. Sauder Woodworking Company, at (888) 800-4590 or www.Sauder.com.
Halloween Mini Projection Lights. The mini projection lights can overheat and melt, posing a burn hazard to consumers. Atico International USA, at (888) 253-6342 or www.aticousa.com/recalls.html.
High Pressure Scuba Diving Air Hoses. The diving hose can rupture reducing the available air supply to the diver, posing a drowning hazard. Innovative Scuba Concepts Inc., at (800) 472-2740 or www.innovativescuba.com, Trident Diving Equipment at (800) 234-3483 or www.tridentdive.com, and A-Plus Marine at (800) 352-2360 or www.aplusmarine.com.
Hustler and BigDog Lawn Mowers. The fuel tank vent valve fitting can fail to seal and cause a fuel leak, posing a fire hazard. Excel Industries Inc., at (800) 748-8223 or www.hustlerturf.com and www.bigdogmowers.com.
Kirkland Signature Six-Quart Sauté Pans with Glass Lids. The pan’s tempered glass lid can crack, break or shatter, posing a laceration hazard to consumers. Costco, at (877) 782-8242 or www.costco.com.
Lawn Mower Engines. The fuel filter can leak, posing a fire hazard. Kawasaki Motors, at (866) 836-4463, or www.kawpower.com.
LG Electric Ranges. Burners on the electric ranges can fail to turn off after being switched off and the temperature setting can increase unexpectedly during use, posing burn and fire hazards to consumers. LG, at (855) 400-4638 or www.LG.com/us.
Liquid Motion Waterslides. The warning labels on the children’s waterslide are inadequate for weight limit and fail to tell consumers never to slide head first. This poses a risk of serious injuries to consumers, including neck injuries. Sportspower, at (888) 965-0565 or www.sportspowerltd.net.
Master Forge Gas Grills. If improperly installed, the hose connecting the gas tank and regulator to the burner control can touch the burner box and cause the hose to melt and rupture when the grill is lit. This poses a fire and burn hazard. Guangdong Vanward Electric, at (888) 584-3648 or www.94227info.com.
Nielsen-Kellerman Microphones. The metal boom of the microphone can conduct electricity from an exposed speaker wire or connector and shock or burn the user. Nielsen-Kellerman, at (800) 784-4221 or www.NKhome.com.
Portable Generators. Fuel can leak from the generator’s carburetor, posing a fire hazard. Champion Power Equipment, at (855) 236-9424 or www.championpowerequipment.com.
Portable Generators. The generator’s fuel hose can leak, posing fire and burn hazards. American Honda, at (888) 888-3139 or http://powerequipment.honda.com.
Powermate Sx 5500 Portable Generators. The fuel filter on this generator allows gasoline to leak, posing a fire hazard. Pramac America LLC, at (800) 445-1805 or www.powermate.com.
Signature Command™ (electronically) Controlled Direct and B-Vent Gas Fireplaces and Inserts. A control component in the fireplaces and inserts can prevent the unit from lighting though gas continues to flow, posing a fire hazard. Monessen Hearth Systems, at (877) 406-9180 or www.mhsc.com.
Tikit Folding Bicycles. The tikit bike’s handlebar stem can break and cause the rider to lose control, posing a fall hazard to the consumer. Bike Friday, at (800) 777-0258 or www.BikeFriday.com.
Toro® Z Master® Riding Mowers. The traction drive belt can wear through the mower’s fuel tank and cause fuel to leak, posing a fire hazard. Toro, at (855) 493-0090 or www.toro.com.
Trampolines. The trampoline’s metal legs can move out of position and puncture the jumping area, posing a risk of injury, including deep, penetrating puncture wounds, cuts and bruises to children and adults on the trampoline. Sportspower, at (888) 965-0565 or www.sportspowerltd.net.
Utility Vehicles. The fuel filter can leak, posing a fire hazard. Deere and Company, at (800) 537-8233 or www.johndeere.com.
Window Fittings. The window fittings can break. This can cause the window to fall, posing an injury hazard to consumers. GU Hardware, at (855) 355-8810 or www.ak-warning.com.