Health Letter, June 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
Actra-SX, 500 Capsules, Maximum Strength Energizer, 500 mg, 5 count package. Volume of product in commerce: 30,000 capsules. Marketed without an approved NDA/ANDA: Product contains sildenafil, an active ingredient in a FDA-approved product for the treatment of erectile dysfunction. Lot #: 008A, expiration date 12/14. Body Basics Inc.
Blue Male Enhancement Pill, bulk product. Volume of product in commerce: 50,000 capsules. Marketed without an approved NDA/ANDA: Product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in an FDA-approved product used for erectile dysfunction, making it an unapproved new drug. Lot #s not specified. The Menz Club, LLC.
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
Ciprofloxacin Tablets USP, 500 mg, 100-count bottle. Volume of product in commerce: 7,136 units. Presence of foreign substance(s): A complaint was received for a rubber-like material in a 500-mg ciprofloxacin tablet. Lot #: CB222A, expiration date 06/16. West-ward Pharmaceutical Corp.
Clonazepam Orally Disintegrating Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6 tablets each). Volume of product in commerce:
3 boxes. Failed content uniformity specifications: Recall is being carried out due to an out-of-specification result for content uniformity. Lot #: 32900136A, expiration date 05/14. Teva Pharmaceuticals USA, Inc.
Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle. Volume of product in commerce: 3,061 bottles. Out-of-specification results for assay at the stability time-point of 24 months. Lot #: 68028A, expiration date 07/14. West-ward Pharmaceutical Corp.
Levoxyl (levothyroxine sodium) Tablets. Multiple dosages, quantities and lots affected. Contact your pharmacist. Chemical contamination: emission of strong odor after package was opened. Pfizer Inc.
Lisinopril and Hydrochlorothiazide Tablets, USP, 20 mg/25 mg, 100- (NDC 60429-046-01) and 1,000- (NDC 60429-046-10) count bottles. Volume of product in commerce: 6,158 bottles. Presence of foreign substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer. Multiple lots affected. GSMS Inc.
Physicians Total Care Tetracycline, 250 mg, 30-capsule bottle. Volume of product in commerce: 1,200 capsules. Presence of foreign substance(s): There is a potential for foreign particulate matter in the API. Lot #s: 69MO, expiration date 05/13; 69SH, expiration date 05/13; 5KXZ, expiration date 05/12; 5RE1, expiration date 05/12. Physicians Total Care, Inc.
Physicians Total Care Tetracycline, 500 mg, 30-capsule bottle. Volume of product in commerce: 3,660 capsules. Presence of foreign substance(s): There is a potential for foreign particulate matter in the API. Multiple lots affected. Physicians Total Care, Inc.
Venlafaxine Hydrochloride Tablets, 75 mg, 100-count tablets per bottle. Volume of product in commerce: 13,320 bottles. Failed tablet/capsule specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle. Lot #: MM8490, expiration date 09/14. Zydus Pharmaceuticals USA Inc.
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
12-Volt Heated Jacket Liners. A defective wire connector can cause the jacket liner to overheat, posing a burn hazard to consumers. Gerbings LLC at (877) 242-5595 or www.gerbing.com.
100-Pound Propane Cylinders. Fuel can leak from the thread connection between the cylinder and valve, posing a fire hazard if exposed to an ignition source. Manchester Tank & Equipment Co. at (800) 640-6327 or www.mantank.com.
2012 Huffy® 20-Inch Slider Tricycle. The handlebar can unexpectedly loosen while in use, causing the rider to lose control. This poses crash and fall hazards for the rider. Huffy at (888) 366-3828 or www.huffybikes.com.
“Aubree’s” and “Hearts” Baby Socks. The flowers and the bows on the baby socks can detach, posing a choking hazard to young children. Trumpette, Inc. at (877) 938-7265 or www.trumpette.com.
Buckyballs and Buckycubes High-Powered Magnet Sets. These products contain defects in the design, warnings and instructions, which pose a substantial risk of injury and death to children and teenagers. Multiple retailers.
CE Tech 1,000 ft. Riser Cable. The riser cable does not meet fire resistance standards for riser cable, posing a fire hazard. Home Depot at (800) 394-7519 or www.homedepot.com.
Chandeliers. Defective wiring can conduct electricity to the chandeliers’ metal parts, posing an electric shock hazard to consumers. Currey & Company at (866) 577-6430 or www.curreyco.com.
Children’s Wooden Puzzles. Small pegs on the puzzle boards can loosen and separate from the boards, posing a choking hazard to children. Small World Toys at (800) 421-4153 or www.smallworldtoys.com.
Compact and Large Handgun Security Vaults. The lock can fail and allow unintended access to the contents of the vault. Battenfeld Technologies Inc. at (877) 509-9160 or www.lockdownvaults.com.
Dollies. The hands on the plush dolls can detach, posing a choking hazard to young children. The Land of Nod at (800) 933-9904
Floor Lamps. A failure of the lamp’s joint locking mechanisms can cause the lamp to collapse and the electrical cord to spark, posing injury and shock hazards to consumers. West Elm at (855) 776-6953 or www.westelm.com.
Giada De Laurentiis Ceramic 9×13 Inch Lasagna Pan. The pan can break causing sharp edges and posing a laceration hazard. Target at (800) 440-0680 or www.target.com.
Gingham Bunny Forks and Spoons for Babies. The pink coloring on the bunny’s ears can come off, posing choking and ingestion hazards to babies. Reed and Barton Corp. at (800) 343-1383 or www.reedandbarton.com.
Girl’s Three-Piece Clothing Sets. The vest sold with these sets has a belt at the waist that could become snagged or caught in small spaces or vehicle doors and it poses an entanglement hazard. Children’s Apparel Network at (800) 919-1917 or www.childrensapparelnetwork.com.
High-Pressure Scuba Diving Air Hoses. The diving hose that connects the regulator to the tank’s pressure gauge can leak, posing a drowning hazard to the user. Trident Diving Equipment at (800) 234-348 or www.TridentDive.com.
Infant Froggy Socks. The stitched knit frog face and feet on the socks can detach, posing a choking hazard to infants and young children. Classic Characters at (877) 298-9620 or www.classiccharacters.com.
Mini Boden Chunky Cord Dungarees. The studs and clasps on the pants can detach, posing a choking hazard to infants and small children. J.P. Boden Services Inc. at (866) 206-9508 or www.bodenusa.com.
One-Piece Footed Infant Clothing with a Zipper. The zipper pull can detach, posing a choking hazard to young children. Carter’s, Inc. at (888) 282-4674 or www.Carters.com.
Urban Shredder Ride-On Toys. Toys can unexpectedly accelerate and cause the rider to lose control, posing a fall hazard. Dynacraft at (800) 551-0032 or www.dynacraftbike.com.