Health Letter, May 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
ABILIFY (aripiprazole) Tablets, 30 mg. Volume of product in commerce: 21 blister packs. CGMP Deviations: A drum of Abilify 30-mg tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed. Lot #: 2E69023A, expiration date 2/28/15. Bristol-Myers Squibb Manufacturing Company.
Citalopram Tablets, USP, 10 mg, 30-count bottle. Volume of product in commerce: 27,805 bottles. Chemical contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell. Lot #: C201028, expiration date 12/13. Dr. Reddy’s Laboratories, Inc.
Citalopram Tablets, USP, 20 mg, 30-count bottle. Volume of product in commerce: 86,093 bottles. Chemical contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell. Lot #: C201922, expiration date 1/14. Dr. Reddy’s Laboratories, Inc.
Citalopram Tablets, USP, 40 mg, 30-count bottle. Volume of product in commerce: unknown. Chemical contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell. Lot #s: C108376, C108634; expiration date 11/13. Dr. Reddy’s Laboratories, Inc.
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules. Volume of product in commerce: unknown. Failed dissolution specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. Multiple lots affected. Amedra Pharmaceuticals LLC.
Isoniazid Tablets, 300-mg tablets USP, 30-tablet and 100-tablet bottles. Volume of product in commerce: 77,531 bottles. Failed dissolution specifications; 36-month stability timepoint. Lot #s: 67079A, 67079B, 67079C; expiration dates unspecified. West-Ward Pharmaceutical Corp.
Meprobamate Tablets, USP, 200 mg, 100 tablets. Volume of product in commerce: 9,824 bottles. Failed impurities/degradation specifications: Out-of-specification result for an impurity, diphenyl sulfone. Lot #s: 386585A, expiration date 02/13; 429104A, expiration date 06/13; 474487A, expiration date 11/13; 491671A, expiration date 01/14. Watson Laboratories Inc.
Meprobamate Tablets, USP, 400 mg, 100 tablets. Volume of product in commerce: 20,587 bottles. Failed impurities/degradation specifications: Out-of-specification result for an impurity, diphenyl sulfone. Lot #s: 387879A, expiration date 02/13; 429105A, expiration date 06/13; 474488A, expiration date 11/13; 491672A, expiration date 01/14; 529095A, expiration date 04/14. Watson Laboratories Inc.
Terazosin Hydrochloride Capsules, 2 mg, packaged in: (a) 100-count bottles, and (b) 1,000-count bottles. Volume of product in commerce: unknown. Presence of foreign tablets/capsules: Recall is being conducted due to a foreign capsule found in one bottle. Multiple lots affected. Teva Pharmaceuticals USA, Inc.
ZARAH® Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg. Volume of product in commerce: 136,720 cartons. Failed tablet/capsule specification: tablet breakage while pushing through the blister pack (dispenser). Lot #s: 401536AA/401536A, 401537AA/401537/A, 401538AA/401538/A, 406985AA/406985A, 432058AA/432058A, 512685AA/512685A; expiration dates unspecified. Watson Laboratories Inc.
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
Aqua Lung Buoyancy Compensators With SureLock II Weight Pocket Handles. The rubber handles can detach as divers are trying to remove the weight pockets to rise to the surface in an emergency, posing a drowning hazard. Aqua Lung at (855) 355-7170 or www.aqualung.com.
Baby High Chairs. The front opening between the tray and seat bottom of the high chair can allow a child’s body to pass through and become entrapped at the neck. This poses a strangulation hazard to young children when the child is not harnessed. BabyHome USA Inc. at (888) 758-5712 or www.babyhome.es.
Basic Beat BB201 Standard Egg Shaker. The outer “end cap” that is glued onto the top, smallest part of the egg can come off, posing a small part choking or aspiration hazard. West Music at (800) 397-9378 or www.westmusic.com.
Bass Guitar Amplifiers. A nut inside the chassis can come loose and fall between the electrical coils, posing an electrical shock hazard to consumers. tc electronic at (800) 349-4699 or www.tcelectronic.com.
Battery-Powered BrightLight™ Blankets. The batteries in the blanket can overheat, posing a burn hazard. IdeaVillage at (866) 655-4342 or www.brightlightblanketrecall.com.
Bell Full Throttle Bike Helmets. The buckle on the helmet’s safety strap can release in an accident and allow the helmet to fall off the rider, posing a risk of head injury. Bell Sports Inc. at (866) 892-6059 or www.bellbikestuff.com.
Bicycle Hydraulic Disc Brakes. The brakes can fail in low temperatures, posing a collision hazard. Magura USA at (800) 448-3876 or www.maguradirect.com.
Break-Barrel Air Rifle. The air gun can discharge while the safety is engaged, posing a risk of injury to consumers and those nearby. Soft Air USA at (866) 763-8247 or www.softairusa.com.
Bugaboo Cameleon3 Strollers. The stroller’s carrying handle can break and detach posing a fall hazard. Bugaboo Americas at (800) 460-2922 or www.bugaboo.com.
Cargo Bike. Passengers’ feet can get caught in the rear wheel, posing a foot injury. Yuba Bicycles at (877) 889-9822 or www.yubabikes.com.
Cha Cha and Cha Cha 2 Girls’ Boots. The zipper pulls on the boots can become entangled posing a fall hazard. Stuart Weitzman, Synclaire Brands U.S.A. at (888) 998-0702 or www.synclaire.com.
Cherry Model Strollers. The opening between the bumper bar and seat bottom of the stroller can allow an infant’s body to pass through and become entrapped at the neck, posing a strangulation hazard to young children when a child is not harnessed. iCandy America at (877) 484-4179 or www.icandyworld.com.
Children’s Pajamas. The pajamas fail to meet federal flammability standards for children’s sleepwear, posing a risk of burn injuries to children. UNIQLO at (877) 486-4756 or www.uniqlo.com.
Filtrete™ Room Air Purifiers.The ion generator in the air purifiers can overheat, posing a fire hazard. 3M Company at (800) 388-3458 or www.filtrete.com/roomairpurifiers.
Garlic Slicers. A blade on the garlic slicer can unexpectedly dislodge during use, posing a laceration hazard to the consumer. The Pampered Chef at (877) 917-2433 or www.pamperedchef.com.
Imaginarium Activity Walkers. The small bolt and spacer that attaches each front wheel to the walker can detach, posing a choking hazard to young children. Toys R Us at (800) 869-7787 or
LED Light Bulbs. The bulbs can overheat during use, posing a fire hazard. Lighting Science Group at (855) 574-2533 or www.lsgc.com/recall.
Martinique LX Jr. Youth Snorkeling Mask Sets. Notches in the tempered glass lens on the mask can break under certain water pressure, posing a laceration hazard to the user. U.S. Divers at (888) 606-6162 or www.usdivers.com.
Nu-Flame Vivo and Vivido Wall-Mounted Fireplaces. Overfilling or spilling fuel while attempting to refill fireplace fuel cups while in place can lead to the fuel cup being ejected from the fireplace, posing a fire or burn hazard to the user, bystanders or items nearby. Bluworld/Nu-Flame at (888) 499-5433 or www.nu-flame.com.
PT Domusindo Perdana Drop-Side Cribs. The cribs’ drop sides can malfunction, detach or otherwise fail, causing part of the drop side to fall out of position, creating a space into which an infant or toddler can roll and become wedged or entrapped, which can lead to strangulation or suffocation. A child can also fall out of the crib. Drop-side incidents can also occur due to incorrect assembly and with age-related wear and tear. Modus Furniture International at (800) 827-2129 or www.savannababy.com.
Santa Cruz Jr. Youth Snorkeling Masks. Notches in the tempered glass can cause the lens to break under certain water pressure, posing a laceration hazard to the user. U.S. Divers at (888) 606-6162 or www.usdivers.com.
SuperCube 2000 Powered Subwoofers. An internal failure with the subwoofer’s level input jack (RCA jack) results in a shock hazard to consumers. Definitive Technology at (800) 228-7148 or www.definitivetechnology.com.
Whitewater Kayaking and Rafting Helmets. The chinstrap buckle can fail, posing a head injury hazard to users. WRSI at (888) 441-1041 or www.whitewaterhelmets.com.
Women’s High-Heel Shoes. The heels on the shoes can become unstable, posing a fall hazard. White House | Black Market at (877) 948-2525 or www.whitehouseblackmarket.com.