Product Recalls: December 5, 2012 – January 1, 2013
Health Letter, February 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
Reumofan Plus Tablets, 30-count bottle per box. Volume of product in commerce: 25,888 boxes. Marketed without an approved NDA/ANDA: contains undeclared drug ingredients, making it an unapproved drug. Lot #s: all lots within expiry through 2016. Samantha Lynn, Inc.
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
Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle. Volume of product in commerce: 120,201 bottles. Presence of particulate matter: Certain batches of atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. Lot #s: 2436144, 2436582, 2441567 and 2441568, expiration date 08/31/2014. Ranbaxy Inc.
Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle. Volume of product in commerce: 203,198 bottles. Presence of particulate matter: Certain batches of atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. Lot #s: multiple lots affected, expiration date 8/31/2014. Ranbaxy Inc.
Atorvastatin Calcium Tablets, 40 mg, 90 tablets per bottle. Volume of product in commerce: unknown. Presence of particulate matter: Certain batches of atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. Lot #s: multiple lots affected, multiple expiration dates. Ranbaxy Inc.
Atorvastatin Calcium Tablets, 40 mg, 500 tablets per bottle. Volume of product in commerce: unknown. Presence of particulate matter: Certain batches of atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. Lot #s: multiple lots affected, expiration date 8/31/2014. Ranbaxy Inc.
Levothroid (Levothyroxine Sodium Tablets), USP 50 mcg, 100-count bottles. Volume of product in commerce: 13,692 100-tablet bottles. cGMP Deviations: Does not meet in-process specification requirements. Lot #: 1097830, expiration date 1/31/2013. Lloyd Inc. of Iowa.
Levothroid (Levothyroxine Sodium Tablets), USP 88 mcg, 100-count bottles. Volume of product in commerce: 31,252 100-tablet bottles. cGMP Deviations: Does not meet in-process specification requirements. Lot #s: 1096369, expiration date 11/30/2012 and 1092046, expiration date 7/31/2012. Lloyd Inc. of Iowa.
Levothroid (Levothyroxine Sodium Tablets), USP 112 mcg, 100-count bottles. Volume of product in commerce: 37,827 100-tablet bottles. cGMP Deviations: Does not meet in-process specification requirements. Lot #s: 1096371, expiration date 5/31/2013, and 1092299, expiration date 1/31/2013. Lloyd Inc. of Iowa.
Levothroid (Levothyroxine Sodium Tablets), USP 125 mcg, 100-count bottles. Volume of product in commerce: 19,162 100-tablet bottles. cGMP Deviations: Does not meet in-process specification requirements. Lot #: 1095210, expiration date 4/30/2013. Lloyd Inc. of Iowa.
Levothroid (Levothyroxine Sodium Tablets), USP 137 mcg, 100-count bottles. Volume of product in commerce: 36,978 100-tablet bottles. cGMP Deviations: Does not meet in-process specification requirements. Lot #s: 1095212, expiration date 4/30/2013; and #1088877, expiration date 11/30/2012. Lloyd Inc. of Iowa.
Levothroid (Levothyroxine Sodium Tablets), USP 300 mcg, 100-count bottles. Volume of product in commerce: 1,443 100-tablet bottles. cGMP Deviations: Does not meet in-process specification requirements. Lot #: 1097178, expiration date 7/31/2013. Lloyd Inc. of Iowa.
Pradaxa (Dabigatran Etexilate), 75 mg capsules, 60-count bottles. Volume of product in commerce: 8,381 bottles. Defective container: Damaged bottles could allow moisture to get into the bottle and may thus impair the quality of the product. Lot #: 201900, expiration date 01/2015. Boehringer Ingelheim Roxane Inc.
Tramadol Hydrochloride Tablets, USP 50 mg, 1,000-count tablets per bottle. Volume of product in commerce: 2,264 bottles. Adulterated presence of foreign tablets: A customer complaint was received that a bottle of tramadol hydrochloride tablets USP 50 mg contained some tablets of metoprolol tartrate tablets USP, 50 mg. Lot #: GKK1373, expiration date 09/2013. Caraco Pharmaceutical Laboratories, Ltd.
CONSUMER PRODUCTS
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
2011 Havoc Bicycles. The bicycle frame can crack at the joint where the top tube meets the down tube. A cracked tube can separate and cause the rider to lose control, posing a risk of injury or death. Norco Bicycles, at (800) 227-5579 or www.norco.com.
2012 PAPYRUS Holiday Signature Ornaments. The presence of Aspergillus mold spores were discovered on the products, posing a risk of respiratory or other infections in individuals with chronic health problems or who have impaired immune systems. Schurman Retail Group, at (855) 730-7998 or www.papyrusonline.com.
2012 PAPYRUS Signature Collection Picture Frames. The presence of Aspergillus mold spores were discovered on the products, posing a risk of respiratory or other infections in individuals with chronic health problems or who have impaired immune systems. Schurman Retail Group, at (855) 730-7998 or www.papyrusonline.com.
2012 PAPYRUS Signature Collection Tree. The presence of Aspergillus mold spores were discovered on the products, posing a risk of respiratory or other infections in individuals with chronic health problems or who have impaired immune systems. Schurman Retail Group, at (855) 730-7998 or www.papyrusonline.com.
All-Terrain Vehicle (ATV). A weld on the ATV’s front right and left upper suspension arms can separate, causing the driver to lose control of the vehicle, posing a crash hazard. American Honda, at (866) 784-1870 or http://powersports.honda.com.
Arctic Cat Snowmobiles. The fuel tank can leak, posing a fire hazard. Arctic Cat, at (800) 279-6851, or www.arcticcat.com.
Artificially Lit Christmas Trees. The Christmas tree base can overheat, posing a fire hazard. GKI Bethlehem Lights, at (800) 248-1434 or www.gkilights.com.
Baby Jogger City Versa™ Strollers. The stroller frame can fail to lock in place and collapse while in use, posing a fall hazard to children in the stroller. Baby Jogger, at (877) 506-2213 or www.babyjogger.com.
Catalina Outdoor Fireplace. The glass components of the Catalina Outdoor Fireplace can break when a fire is lit, posing a burn and laceration hazard. Christmas Tree Shops, at (888) 287-3232 or www.christmastreeshops.com.
Classic by Easy-Rest Foam Core Mattresses. The mattresses fail to meet the mandatory federal open flame standard for mattresses, posing a fire hazard to consumers. Easy-Rest Inc., at (602) 442-6609 or www.easyrestinc.com.
Dream On Me Bath Seats. The bath seats fail to meet federal safety standards, including the requirements for stability. Specifically, the bath seats can tip over, posing a risk of drowning to babies. Dream On Me, at (877) 201-4317 or online at www.dreamonme.com.
Dream On Me Bed Rails. The bed rail can separate from the mattress allowing a child’s body to become entrapped if it slips between the rail and the mattress. This poses suffocation and strangulation hazards to children. Dream On Me, at (877) 201-4317 or online at www.dreamonme.com.
Falls Creek Kids Infant and Toddler Denim Jeans. The snap on the front of the infant and toddler denim jeans may come loose and separate from the fabric, posing a choking hazard to young children. Meijer, at (800) 927-8699 or www.meijer.com.
High-Powered Magnet Desk Toy. When two or more magnets are swallowed, they can link together inside a child’s intestines and clamp onto body tissues, causing intestinal obstructions, perforations, sepsis and death. Internal injury from magnets can pose serious, lifelong health effects. Reiss Innovations, at (866) 212-8314 or www.DynoCube.com.
Home Depot Mug. The silver-colored simulated bucket handle below the rim can spark when used in a microwave oven, posing a fire hazard. Home Depot, at (877) 527-0313 or www.homedepot.com.
Izoard XP Bicycles. The bicycle fork’s steerer tube can break while in use, posing a fall hazard. Wilier USA, at (888) 849-7779 or www.wilier-usa.com.
Jotul and Scan Gas Fireplace Inserts. The fireplace insert’s electrical wiring can come into contact with the metal rating plate on the insert, posing electrical shock and burn hazards to consumers. Jotul North America, at (800) 797-5912 or www.jotul.com.
Leg Press. The weight platform locking mechanism can fail and the backrest can disengage during normal use, posing a risk of injury to the consumer. Cybex International, at (888) 678-3846 or www.cybexintl.com.
Low Lead Ball Valve/Shut-Off Gas Valves. The valves can crack and cause gas to leak. This poses fire and explosion hazards. Danville Sales Office for Fu San Machinery, at (855) 779-9200 or www.fsvalve.com.tw.
Mattresses and Mattresses with Foundations. The mattresses fail to meet the mandatory federal open flame standard for mattresses, posing a fire hazard to consumers. American Mattress Manufacturing, at (855) 628-6344 or www.americanmattressmfg.com.
Metal Chairs. The chairs’ back legs can bend when a seated person leans back. This poses fall and injury hazards to consumers. Grandin Road, at (888) 298-4651 or www.grandinroad.com.
Muddy Outdoors Tree Climbing Sticks. The climbing sticks can break, posing risk of serious injury or death to users. Muddy Outdoors, at (877) 366-8339 or www.gomuddy.com.
RIDGID Coil Roofing Nailer and RIDGID Clipped Head Framing Nailer. The trigger assembly on the nailers can malfunction and involuntarily discharge a fastener, posing a laceration or injury hazard to consumers. One World Technologies, at (800) 597-9624 or www.ridgid.com.
Sassy®-branded Hug N’ Tug Puppy and Monkey and Carter’s®-branded Hug N’ Tug Monkey Toys. The beads inside the clear plastic sphere at the center of the toys can be released and pose a choking hazard to young children. Sassy, at (800) 323-6336 or www.sassybaby.com.
Shelly’s Diner® Collectible Ceramic. The diner’s power adapter can overheat and melt the adapter’s plastic housing, posing a fire hazard. Enesco, LLC, at (800) 436-3726 or www.department56.com/recall.
Snowmobiles. The bolt attaching the front, lower left shock can fail and cause the operator to lose control of the vehicle. This poses a serious hazard of injury or death. Polaris, at (888) 704-5290 or www.polaris.com.
Stepladder and Stepstool Combination. When extended, the inner side rails can separate from the outer side rails, causing the user to fall. Wing Enterprises Inc., at (855) 595-3378 or www.littlegiantladders.com/switch-it-recall.
Top-Loading Washing Machines. An unbalanced load can cause the washing machine to shake excessively and the drum to come loose during use, posing a risk of injury to consumers and property damage to the surrounding area. LG, at (855) 400-4639 orwww.lg.com/us.
Water Balz, Growing Skulls, H2O Orbs “Despicable Me” and Fabulous Flowers Toys. When the marble-sized toy is ingested, it expands inside the body and causes a blockage in the small intestine, resulting in severe discomfort, vomiting and dehydration, which could be life threatening. The toys do not show up on an X-ray and require surgery to be removed from the body. Dunecraft Inc., at (800) 306-4168, or www.dunecraft.com.
WFT-E7A Wireless File Transmitter. A chemical used in the rubber part on the top cover of the product can result in a reaction that changes the rubber from black to white and poses a risk of skin irritation to the consumer. Canon, at (855) 902-3277 or www.usa.canon.com.