Health Letter, November 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
Bethel 30 capsules, 30-count bottles. Volume of product in commerce: 18,678 bottles. Lot #: 120514, expiration date 12/2014. Marketed without an approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug. Bethel Nutritional Consulting, Inc.
Enteric Coated Aspirin (NSAID), 81 mg, 120-count tablets per bottle. Volume of product in commerce: 16,440 bottles . Lot #: 13A026, expiration date 01/2015. Label mix-up: A complaint from a pharmacist was received that the entire contents of one bottle labeled as Rugby label Enteric Coated Aspirin 81 mg tablets actually contained acetaminophen 500 mg tablets. Advance Pharmaceutical.
SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles. Volume of product in commerce: 673,851 capsules. Lot #s: All lots of product distributed and sold from January 2012 to May 7, 2013, SKUs: 626570609490, 827912089028, 626570617877, 626570615316, 626570623588. Marketed without an approved NDA/ANDA: Products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug. Beamonstar Products.
Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles. Volume of product in commerce: 145,632 capsules. Lot #s: All lots of product distributed and sold from January 2012 to May 7, 2013. SKUs: SKUs 626570613855, 626570619055, 626570617860, 626570617563. Marketed without an approved NDA/ANDA: Products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug. Beamonstar Products.
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
Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital, USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04). Volume of product in commerce: 270 tablets. Lot# 6GP2; expiration date 10/2014. Presence of foreign substance: The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall. Physicians Total Care Inc.
IBU brand Ibuprofen Tablets, USP, 800 mg, 500-count bottle. Volume of product in commerce: 18,852 bottles. Lot # 300192, expiration date 5/2017. Labeling: Incorrect or missing lot and/or expiration date: This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016. Dr. Reddy’s Laboratories.
Propranolol Hydrochloride Tablets, USP, 10 mg, 1,000-count bottles. Volume of product in commerce: 9003 bottles. Lot #s: 6A301029, expiration date 1/2016; 6A303025, expiration date 3/2016. Failed tablet/capsule specification: Some tablets potentially not conforming to weight specification. Teva Pharmaceuticals USA.
Rifadin (rifampin) Capsules, USP, 150 mg, 30-count capsules per bottle. Volume of product in commerce: 2,462 bottles. Lot #: 3097657, expiration date 03/2015. Subpotent drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment. Sanofi-Synthelabo.
Rifadin (rifampin) Capsules, USP, 150 mg, 100-count capsules per bottle. Volume of product in commerce: 998 bottles. Lot #: 3099036, expiration date 03/2014. Subpotent drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment. Sanofi-Synthelabo.
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
BBQ Ant Votive Candle Holders. The decorative ant’s arms, used to hold up the votive cup, can break. If this happens, a lit candle can tip over or fall out, posing fire and burn hazards. Mercuries Asia at (800) 828-9316 or www.ma-recall.com.
Car Seat Adaptor for Strollers. The car seat adaptor support bars can fail, posing a fall hazard to children. Baby Jogger® at (877) 506-2213 or www.babyjogger.com.
Ceiling-Mounted Light Fixture. The fixture’s socket wire insulation can degrade and lead 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 Designs Inc. at (855) 553-6526.
Chefmate 2-Quart Tea Kettles. Steam can travel up the handle, or water can spill from the spout, posing a burn hazard to the consumer. In addition, the leaking steam can cause the kettle to fail to whistle. If water completely evaporates from the kettle, the aluminum bottom can melt onto the stove and pose a burn hazard. Wilton Industries at (866) 255-9237 or www.wilton.com.
Children’s books titled “Count my Kisses, 1, 2, 3” and “Red, Green, Blue, I Love You.” A metal rod holding small beads on the cover of books can detach and release small parts that present a choking hazard. A detached metal bar can expose a sharp edge posing a laceration hazard. Hachette Book Group at (888) 965-5802 or www.hachettebookrecall.com.
Children’s One-piece Footed Pajamas. The footed pajamas fail to meet the federal flammability standard for children’s sleepwear, posing a burn hazard to children. The garments are being recalled because they do not meet the tight-fitting sizing requirements. The Children’s Place at (877) 752-2387 or www.childrensplace.com.
Children’s Two-Piece Loungewear Sets. The loungewear garments fail to meet children’s sleepwear federal flammability standards which require sleepwear, including loungewear, to be either snug-fitting or flame resistant, posing a risk of burn injuries to children. Apple Park at (866) 708-4695 or www.applepark.com.
Dehumidifiers. The dehumidifiers can overheat, smoke and catch fire, posing fire and burn hazards to consumers. Gree toll-free at (866) 853-2802 or www.greeusa.com.
Disc Brake Calipers. The calipers on the disc brakes can fail, posing a collision hazard. Shimano American at (800) 353-4719 or www.shimano.com.
Frigidaire Professional Blenders. The blender’s blade shaft assembly can break during use, posing a laceration hazard to consumers. Frigidaire toll-free at (888) 747-7637 or www.frigidaire.com.
HALO® SleepSack® Wearable Blankets with Pink Satin Flowers. Petals from the floral embellishment on the blankets can detach, posing a choking hazard to infants. Halo Innovations at (866) 819-8118 or www.halosleep.com.
Journey Girl Travel Trunk. The blue metal handle on the trunk can be sharp, presenting a laceration hazard to the user. Toys R Us at (800) 869-7787 or www.toysrus.com.
L.L.Bean Deluxe Packaway Boat Carts. The cart’s plastic wheel rims can burst when the rubber tires are over-inflated, posing an injury hazard to consumers. L.L.Bean Inc. at (800) 555-9717 or www.llbean.com.
Motorcycle Training Wheels. Bolts and nuts securing the wheel can loosen and cause the rider to lose control, posing a crash hazard. Cambridge Metal & Plastics at (800) 457-0580 or www.cmp-wwm.com.
TS 55 REQ Plunge Cut Circular Saw. The plunge lock can engage when not intended, causing the saw blade to remain exposed from the housing following completion of the plunge cut and posing a laceration hazard. Festool USA toll-free at (855) 784-9727 or www.festoolusa.com.
Visonic Amber Classic and Amber SelectX Personal Emergency Response System (PERS) Kits. A single Amber Base station set to Common Area Mode will not detect a low battery or dead battery warning signal from the remote pendant that notifies the end user or system administrator to replace the pendant battery. Visonic at (800) 223-0020 or www.visonic.com.
Vitamix 64-ounce Low-Profile Container. The blade can break, creating a laceration hazard to consumers. Vitamix at (888) 350-4386 or www.ContainerBladeRecall.com.
Water-absorbing Polymer Balls. The soft and colorful product can be mistaken by a child for candy. When the marble-sized toy is ingested, it can expand inside a child’s body and cause intestinal obstructions, resulting in severe discomfort, vomiting, dehydration and could be life threatening. The toys do not show up on an x-ray and need surgery to be removed from the body. Be Amazing! Toys at (877) 798-9795 or www.beamazingtoys.com.