Health Letter, December 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
Acetaminophen Tablets, 500 mg, 100-count bottles. Volume of product in commerce: 28,387 bottles. Lot #: 3213, expiration date 12/2013. CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm. Marlex Pharmaceuticals, Inc.
Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100-count bottles. Volume of product in commerce: 10,615 bottles. Lot #: 705791A, expiration date 04/2015. Presence of foreign tablets/capsules: 20 tablets of oxycodone/APAP 7.5/500 mg were found in a sealed 100-count bottle of oxycodone and acetaminophen tablets. Watson Laboratories Inc.
Pyridostigmine Bromide Tablets, USP. Volume of product in commerce: 960 bottles. Lot # 109497; expiration date 12/2015. Failed Stability Specifications: Product is being recalled due to an out-of-specification test result during stability testing. Core Pharma 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
A/C Adaptor (charger) Included with Polaroid PMID 709 Internet Tablets. The adaptors can overheat, posing a fire hazard. Southern Telecom at (866) 450-4493 or www.southerntelecom.com.
All-Terrain Vehicles (ATVs). The ATV’s steering shaft can break unexpectedly and cause the rider to lose steering control and crash. This poses a risk of injury or death to riders. American Honda at (866) 784-1870 or http://powersports.honda.com.
APC SurgeArrest Surge Protectors. The surge protectors can overheat, smoke and melt, posing a fire hazard. Schneider Electric IT Corp. at (888) 437-4007 or www.apc.com.
BreathableSack Wearable Blanket for Infants. The zipper pull tabs and sliders can detach posing a choking hazard to infants. BreathableBaby at (877) 827-4442 or www.breathablebaby.com.
Building Toy Playsets. The plastic hats found on playset figures pose a choking/aspiration hazard for children. Infinitoy, Inc. at (888) 558-0933 or www.infinitoy.com.
Circo-brand Chloe and Conner Sitting Stools. The stabilizing bar can crack and cause the stool to collapse, posing a fall hazard to the user. Target Guest Relations at (800) 440-0680 or e-mail email@example.com.
Hanging Pendant Lamps. The lamp’s wires can be connected incorrectly because the wires’ polarity labels can fall off or be mislabeled, posing fire and shock hazards to consumers. Crate and Barrel at (800) 451-8217 or www.crateandbarrel.com.
Motion-Activated Outdoor Lights. The internal fixture wiring can energize the entire surface and fittings of the fixture, posing an electrical shock hazard. HeathCo at (855) 704-5438 or www.heath-zenith.com.
Snoopy Sno-Cone Machines. A brass rivet can fall out of the sno-cone machine’s ice-shaving cylinder and into a sno-cone, posing a risk of injury to the mouth or the teeth. LaRose Industries at (855) 345-4693 or www.laroseindustries.com.
Tommy Bahama® Outdoor Ceiling Fans. The brackets holding the fan blades can break and cause the blades to fall, posing a risk of injury to bystanders. Emerson Air Comfort Products at (866) 994-8759 or www.emersonfans.com.
Trail Crest Boys and Girls Hooded Sweatshirts and Jackets. The hoodies and jackets have drawstrings through the hood or neck which pose a strangulation hazard to young children. In February 1996, CPSC issued guidelines about drawstrings in children’s upper outerwear. In 1997, those guidelines were incorporated into a voluntary standard. Then, in July 2011, based on the guidelines and voluntary standard, CPSC issued a federal regulation. CPSC’s actions demonstrate a commitment to help prevent children from strangling or getting entangled on neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. Trail Crest at (800) 965-6550 or e-mail firstname.lastname@example.org.