Health Letter, September 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
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets, 0.25mg/0.035mg, 3 x 28 tablets per carton. Volume of product in commerce: 10,848 cartons. Lot #: LF01213A, expiration date 02/2014. Contraceptive tablets out of sequence: A placebo tablet was found in a row of active tablets. Sandoz Incorporated.
Nimodipine Capsules, 30 mg. Volume of product in commerce: 46,387 cartons. Multiple lots, multiple expiration dates. Contact your pharmacist. Crystallization: crystallized nimodipine. Sun Pharmaceutical Industries Inc.
Pure-Aid Allergy Relief, diphenhydramine HCL caplets, 25 mg, 20 caplets. Volume of product in commerce: 24,048 cartons. Lot #s: 6781202 and 6781302, expiration dates not specified. Labeling: Not elsewhere classified; foil label on immediate blister pack indicates active ingredient as chlorpheniramine rather than diphenhydramine. Kareway Product Inc.
Quetiapine Fumarate Tablets, 25 mg, 100-tablet blister card. Volume of product in commerce: 19,060 blister cards. Lot #: 122600, expiration date 03/2014. Failed dissolution test requirements: During analysis of long-term stability studies at three months, an out-of-specification (OOS) was reported. American Health Packaging.
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
Autumn Run Girls Gemma II Boots. An exposed staple in the sole of the boot presents a laceration hazard to the consumer. Renaissance Imports at (877) 632-2021 or www.renimp.com.
Baby Einstein Musical Motion Activity Jumpers. The “sun” toy attachment on the activity jumper can rebound with force and injure the infant, posing an impact hazard. Kids II at (877) 325-7056 or
Boy’s Long-Sleeve Hooded Jackets. The recalled jackets have drawstrings with toggles inside the bottom hem and neck area, posing a strangulation hazard to children. Mecca 5 Star at (880) 229-6833 or e-mail email@example.com.
Decorative Lamps. The lamps have exposed wiring at the base. This poses shock and fire hazards to consumers. Angel’s Touch Collections at (877) 474-2133 or www.angeltouchcollections.com.
Electric Smokehouse Smokers. The wood chip tray can fail to slide securely into the smoker, causing the wood to combust and the smoker’s cabinet door to blow open, posing a fire hazard. Masterbuilt Manufacturing at (800) 489-1581 or www.masterbuilt.com.
Hollis DG03 Dive Computers. The dive computer, when used with an optional integrated transmitter, can malfunction and display an incorrect tank pressure reading to the diver. A diver could unknowingly deplete their air supply based on the reading, resulting in drowning. Hollis toll-free at (888) 383-3483 or www.hollisgear.com.
Infants’ First Impressions Varsity Jackets. The snaps on the jackets can come off, posing a choking hazard. Macy’s at (888) 257-5949 or www.macys.com.
Johnny G. Krankcycle® by Matrix. The seat can unexpectedly detach from the Krankcycle’s frame during use, posing a fall hazard to users. Johnson Health Tech North America at (866) 218-3674 or www.matrixfitness.com.
Kenmore Dehumidifiers. The dehumidifiers can overheat, smoke, melt and catch on fire, posing fire and burn hazards to consumers. LG Recall Fulfillment Center at (855) 400-4641 or www.kenmoredehumidifierrecall.com.
Loose Votive Candles. The candles can burn with a high flame, posing a fire and burn hazard. Swan Creek Candle Co. at (888) 804-8492 or www.swancreeekcandle.com.
Outdoor Solutions Hammock with Sunshade. The seam in the lounge of the hammock can open and rip, posing a fall hazard. H-E-B at (800) 432-3113 or www.heb.com.
Portable Generators. The fuel tank can leak, posing a fire or burn hazard. Robin America Inc. at (866) 664-1363 or www.subarupower.com.
Remote-Controlled 3-Channel Helicopters. The rechargeable battery inside the helicopters can overheat, posing fire and burn hazards to consumers or nearby items. Toys R Us at (800) 869-7787 or www.toysrus.com.
Rockland Furniture Round Cribs. The crib’s drop-side rails can malfunction, detach or otherwise fail. When this happens, the drop-side rail can fall out of position and create a space where an infant or toddler can become wedged or entrapped, posing a risk of strangulation or suffocation. A child can also fall out of the crib. In addition, drop-side related incidents can also occur due to incorrect assembly and with age-related wear and tear. Rockland Furniture at (877) 967-5770 or www.rocklandimmobilizationkit.com.
Soleil Portable Fan Heaters. The portable fans’ plastic housing can melt, deform and catch fire during use, posing a fire hazard. Home Depot at (877) 527-0313 or www.homedepot.com.
Tern Folding Bicycles. The bike’s frame can crack at the hinge on the top tube, posing a fall hazard. Stile Products at (888) 570-8376 or www.ternbicycles.com.
Thermobaby Aquababy Bath Ring Seats. The bath seats fail to meet federal safety standards, including the requirement for stability. Specifically, the bath seats can tip over, posing a risk of drowning to babies. SCS Direct Inc. at (888) 749-1387 or www.SCSdirectinc.com.
UCO Arka LED Lanterns. The lantern’s wall charger plug can fail during normal use, posing a fire hazard. Industrial Revolution at (888) 297-6062 or www.industrialrev.com.
Viking Built-In Refrigerators with Bottom Freezers. The refrigerator’s doors can detach, posing an injury hazard to consumers. Viking at (877) 546-0136 or www.vikingrange.com.