Health Letter, April 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. Volume of product in commerce: 897,379 bottles. Superpotent (multiple-ingredient) drug: Complaint received of oversized tablets. Multiple lots affected. Contact your pharmacist. Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton. Volume of product in commerce: 3,407 cartons. Superpotent (multiple-ingredient) drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. Lot #s: 3037841, 3040859 and 3042573, expiration date 12/2013. Mylan Institutional, Inc. dba UDL Laboratories.
SLIM XTREME Herbal Slimming Capsules, 30-count bottles. Volume of product in commerce: 40,400 bottles. Marketed without an approved NDA/ANDA: Product tested positive for sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug. Lot #s: All lots of SlimXtreme with the following format stamped in black ink on the bottom of the bottle “MFD: XX.XX.20XX EXP: XX.XX.20XX”, which were manufactured overseas, are being recalled. Globe All Wellness, LLC.
SLIMDIA Revolution Capsules, 30-count capsules per bottle. Volume of product in commerce: unknown. Marketed without an approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug. Lot #s: There are no manufacturing codes associated with the product. Yerba Naturals, P & J Trading Co.
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
Carisoprodol Tablets, USP, 350 mg, packaged in: (a) 500-count tablets per bottle (NDC 0143-1176-05) and (b) 1,000-count tablets per bottle (NDC 0143-1176-10). Volume of product in commerce: 8,585 bottles. Presence of foreign substance: Uncharacteristic black spots on tablets. Lot #s: 69364A, 69365A and 69365B, expiration date 10/2015. West-ward Pharmaceutical Corp.
Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle. Volume of product in commerce: 11,580 bottles. Failed tablet/capsule specifications: Product exceeds specification for tablet weight and tablet thickness. Lot #s: ZCMH12031, ZCMH12032, ZCMH12033 and ZCMH12034, expiration date 02/2014. Mylan Pharmaceuticals Inc.
Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle. Volume of product in commerce: 1,894 bottles. Presence of foreign tablets/capsules: Bottles of lansoprazole 30 mg, delayed-release capsules may contain topiramate 100 mg tablets.
Lot #: 1110829, expiration date 05/2014. Mylan Pharmaceuticals Inc.
PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1,000-count tablets per bottle (NDC 0143-1473-10). Volume of product in commerce: 128,319 bottles. Presence of foreign substance: Tablets are being recalled due to gray defects identified in the tablets. Multiple lots affected. West-ward Pharmaceutical Corp.
Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules. Volume of product in commerce: 60 bottles. Failed dissolution test requirements. Lot #308198, expiration date 03/2014. Upsher Smith Laboratories, Inc.
Taztia XT Capsules (diltiazem HCI extended release capsules, USP, once-a-day dosage, 360 mg, 90 capsules per bottle. Volume of product in commerce: 3,040 bottles. Failed dissolution specification: Out-of-specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%). Lot #: 512146A, expiration date 01/31/2014. Watson Pharmaceuticals.
Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, for oral administration. Volume of product in commerce: 17,169 packages. Failed impurities/degradation specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring. Lot #: 0NCW005, expiration date 02/2013. Schering-Plough Products, LLC.
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
4moms® breeze™ Cotton Jersey Playard Sheets. The sheets are too small for the play yards. A sheet that does not properly fit the play yard poses an entrapment hazard that could lead to suffocation. 4moms, at (888) 977-3944 or www.4moms.com.
Beamerzzz™ Stuffed Animals with LED Flashlight. LED flashlight wires can protrude through the stuffed toy, posing a laceration hazard. Purr-Fection by MJC, at (800) 359-0254 or www.purr-fection.com.
BlueStar™ Residential Gas Wall Ovens. Some of the wall ovens have been improperly installed and/or have damaged flexible gas appliance connectors, posing a fire hazard. BlueStar, at (800) 449-8691 or www.bluestarcooking.com.
Canning Jar Lifter. The jar lifter handle can detach over time due to a missing stainless steel core in the hinge. This can cause the tongs to fail to grip and allow a jar being lifted to fall, posing a laceration hazard to the user. Progressive International Corporation Customer Service, at (800) 426-7101 or www.progressiveintl.com.
Dual-Wattage Travel Converter Kits. The converter can overheat if a load in excess of 50 watts is applied to the converter while in the 50-watt setting. This poses a fire and burn hazard to consumers. Samsonite, at (800) 382-7259 or www.samsonite.com.
Easy Go XP Lock Via Ferrata Lanyards. The elastic webbing on the lanyards can deteriorate over time and break while in use, posing a risk of serious injury or death to the climber. Liberty Mountain, at (800) 366-2666 or www.libertymountain.com.
EVO Strollers. The opening between the grab 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. Mutsy USA, at (877) 546-9230 or
Expert Gardener Electric Blower Vacuums. Objects that are drawn into the unit during vacuum mode can break through the plastic
housing, posing a laceration hazard. OWT Industries Inc., at (800) 597-9624 or www.expertgardenertools.com.
Homelite Electric Blower Vacuums. Objects that are drawn into the unit during vacuum mode can break through the plastic housing, posing a laceration hazard. Homelite Consumer Products, at (800) 597-9624 or www.homelite.com.
Middleton Siege Crossbows. The crossbow can fire unexpectedly when the auto-safety mechanism appears to be on and the trigger is pulled, posing an injury hazard to the user and bystanders. In addition, the crossbow limbs can crack or break under normal use. The Bohning Company, Ltd., at (800) 253-0136 or www.bohning.com.
Motor Scooters with Hello Kitty or Monster High Graphics. The scooters can accelerate suddenly while in use, causing the rider to lose control and fall. Dynacraft, at (800) 551-0032 or www.dynacraftbike.com.
One-cup Coffeemakers. The coffeemaker can overheat, posing fire and burn hazards to consumers. Jerdon Style, at (800) 223-3571 or www.jerdonstyle.com.
Pre-lit Artificial Christmas Trees. The remote control receiver box attached to the Christmas tree can overheat and melt, posing burn and shock hazards to consumers. Balsam Hill, at (877) 694-2752 or www.balsamhill.com.
Ryobi Lithium 18V 4Ah Battery Pack. The battery pack can overheat and burst while on a charger, posing fire and burn hazards to consumers. One World Technologies, at (800) 597-9624 or www.ryobitools.com.
Ski-Doo® Snowmobiles. The fuel pump inlet fitting can come into contact with the oil tank and break, leading to a fuel leak, which poses a fire hazard. BRP, at (888) 638-5397 or www.ski-doo.com.
SlumberWorld Mattresses. The mattresses fail to meet the mandatory federal open flame standard for mattresses, posing a fire hazard to consumers. SlumberWorld, at (808) 421-3159 or www.slumberworldhawaii.com.
Task*It 1-UP Folding Step Stool. The folding step stool can crack or break and collapse, posing a fall hazard to the user. Cramer LLC, at (800) 366-6700 or www.cramerinc.com.
Utility Vehicles. The oil filter can leak, posing a fire hazard. Pinholes or cracks have been identified in oil filters installed by the engine supplier that were not manufactured to specification. Deere and Company, at (800) 537-8233 or www.johndeere.com.