HEALTH AND SAFETY

» Drug, Devices, and Supplements

» Physician Accountability

» Consumer Product Safety

» Worker Safety

» Health Care Delivery

» Auto and Truck Safety

» Global Access to Medicines

» Infant Formula Marketing

 

Health Letter Archive


How to order a print version of Health Letter

You may order back issues, which are available for $3.00 each. If you have questions about Health Letter, please call (202) 588-1000 and ask to speak with a representative from the Health Research Group.

Ordering by credit card

Call Member Services at (202) 588-1000 to order by credit card. Public Citizen accepts Visa, MasterCard, American Express and Discover. Unfortunately, it is not currently possible to order the Health Letter online.

Ordering by check

Mail a check payable to Public Citizen to:

Health Letter
1600 20th Street NW
Washington, DC 20009

Health Letter Cumulative Alphabetical Subject index

View a comprehensive list of subjects covered in Health Letter from its first issue in 1985 through the present.

Copyright © Health Letter.
All rights reserved.
Material appearing in Health Letter may not be reprinted without permission from the editor.

Product Recalls

April 3, 2013 – April 30, 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.

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

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
or www.landofnod.com.

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 9x13 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.

Copyright © 2014 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.


Public Citizen, Inc. and Public Citizen Foundation

 

Together, two separate corporate entities called Public Citizen, Inc. and Public Citizen Foundation, Inc., form Public Citizen. Both entities are part of the same overall organization, and this Web site refers to the two organizations collectively as Public Citizen.

Although the work of the two components overlaps, some activities are done by one component and not the other. The primary distinction is with respect to lobbying activity. Public Citizen, Inc., an IRS § 501(c)(4) entity, lobbies Congress to advance Public Citizen’s mission of protecting public health and safety, advancing government transparency, and urging corporate accountability. Public Citizen Foundation, however, is an IRS § 501(c)(3) organization. Accordingly, its ability to engage in lobbying is limited by federal law, but it may receive donations that are tax-deductible by the contributor. Public Citizen Inc. does most of the lobbying activity discussed on the Public Citizen Web site. Public Citizen Foundation performs most of the litigation and education activities discussed on the Web site.

You may make a contribution to Public Citizen, Inc., Public Citizen Foundation, or both. Contributions to both organizations are used to support our public interest work. However, each Public Citizen component will use only the funds contributed directly to it to carry out the activities it conducts as part of Public Citizen’s mission. Only gifts to the Foundation are tax-deductible. Individuals who want to join Public Citizen should make a contribution to Public Citizen, Inc., which will not be tax deductible.

 

To become a member of Public Citizen, click here.
To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.