Tagged Articles

recalled products 214 articles

New rules for heart scan aims to reduce excessive radiation exposure

Instructions for a recalled device and drug used to produce scans to evaluate the heart have been revised in an effort to determine what may have caused excess radiation in some patients. The CardioGen-82 PET scan, made by Bracco Diagnostics Inc., is used to perform cardiac positron emission tomography (PET) scans with the radioactive drug rubidium (Rb)-82 chloride injection to evaluate the heart. The Food and Drug Administration (FDA) has received reports of two patients who received more radiation than expected from CardioGen-82. The excess radiation was due to strontium isotopes which may have been inadvertently injected into the patients ... Read More

Johnson & Johnson sold unapproved transvaginal mesh for years, report claims

Johnson & Johnson sold its Gynecare Prolift vaginal mesh for three years without obtaining approval for the product, according to a March 21 report by Bloomberg. The Prolift mesh, which the U.S. Food and Drug Administration (FDA) eventually approved for use in 2008, is now the source of about 550 personal injury lawsuits in the U.S., filed by women who allege the product malfunctioned and harmed them. To gain FDA approval, manufacturers of medical devices such as surgical mesh and bladder slings must demonstrate that the products either have passed required clinical tests for safety and efficacy or are sufficiently ... Read More

Feds probe sudden unintended acceleration in Ford and Mercury vehicles

Federal regulators investigating the potential for sudden unintended acceleration in Ford and Mercury cars expanded their probe this week to encompass nearly 2 million vehicles. The National Highway Traffic Safety Administration launched its investigation on Sunday in response to a number of complaints it received of Ford Taurus cars suddenly accelerating on their own. The investigation started with 360,000 2005-2006 Taurus Sedans, but on Monday grew to include another 1.56 million vehicles, including Taurus and Mercury Sable sedans made in the 2001 through 2005 model years. Reminiscent of the sudden unintended acceleration recalls that sent millions of Toyota and Lexus ... Read More

Anti-smoking drug Chantix may help other addicts, but at what cost?

Two new clinical studies have found evidence that Pfizers’s anti-smoking drug Chantix (varenicline) may help take the enjoyment out of cocaine and alcohol in much the same way it makes smoking cigarettes feel less desirable, thereby easing addiction and making it easier for users to quit. The news will certainly be welcomed by manufacturer Pfizer, which had counted on Chantix being a major moneymaker before sales of the drug dropped off following reports linking it to cases of suicide and hostile behavior. But numerous other studies and clinical data suggest Chantix is far from being a sound panacea for addictions, ... Read More

Report suggests poor safety auditor advice contributed to deadly Listeria outbreak

A Congressional Committee’s investigation of the Colorado family farm linked to a nationwide outbreak of Listeria last summer found that a third-party auditor gave the farm a “superior” rating just weeks before the outbreak, calling into question the reliability and credibility of private agricultural inspection firms. The outbreak was traced to cantaloupes grown on the farm. The House Energy and Commerce Committee report says that Jensen Farms of Rocky Ford, Colorado hired Bio Food Safety Inc., a subcontractor working for Primus Labs, to evaluate its operations in 2010 and again in 2011. However, the auditor focused only on Jensen Farms’ ... Read More

Space heater recalls you should know about

The U.S. Consumer Products Safety Commission urges caution when using portable heating devices, and has compiled a list of heaters that have been recalled for flaws or defects that pose a risk of fire. While these heaters should not show up new on retail store shelves, many could turn up in yard sales, thrift stores, and flea markets. Many more may still be in use in private homes throughout the country. Before you buy or use a portable heating device this winter, be sure to check this list to make the device doesn’t pose a safety flaw that could create ... Read More

FDA warns of strangulation risk with personal massager

The strangulation death of one person and the near-strangulation of another have prompted the Food and Drug Administration (FDA) to issue a warning to consumers not to use the ShoulderFlex Massager, imported by King International and sold in retail stores, in catalogs and online by various companies. The personal massager is designed to provide deep tissue massage to the neck, shoulders and back area while lying down; however, hair, clothing and jewelry can become entangled in the massager and begin to strangle users. The FDA first warned about the device on August 31, when the manufacturer recalled the massager. During a compliance ... Read More

CPSC announces improvements to product safety database

The U.S. Consumer Product Safety Commission’s new product safety database has been online only since early March, but the agency has announced some key changes it says will improve ease of use and efficiency for businesses. The SaferProducts.gov database functions as both a publicly accessible library of safety information concerning more than 15,000 types of consumer products and as a forum where consumers and businesses can publicly address complaints. Now a new online form in the business portal of the Saferproducts.gov website provides manufacturers, private labelers, and importers a quicker and easier way to communicate with the CPSC about product ... Read More

FDA’s cantaloupe farm inspection sheds light on listeria outbreak, audit failures

Jensen Farms hired a private, third-party auditor to inspect several changes it made to its cantaloupe packing facilities earlier in the summer just before the deadly outbreak of listeria linked to its products, but the auditor failed to recognize the problems in the plant. Jensen Farms, based in Jensen, Colorado, hired food-safety corporation Primus Labs to conduct the audit. Primus Labs then subcontracted the work to a Texas firm called BioFood Safety, and the audit was performed in July. Although the audit acknowledged certain changes and methods that federal regulators later blamed for the outbreak, the firm gave the farm ... Read More

Contact lens manufacturer accused of downplaying recall, injuring consumers

Contact lens manufacturer CooperVision Inc. is being accused by consumers of downplaying a recall of its Avaira Toric contact lenses. The lenses, distributed at Costco, Wal-Mart and LensCrafters retail stores, are linked to eye problems including blurry vision, scratched corneas, and even severe cornea tears. Although the company issued a voluntary recall of the lenses on Aug. 19, and notified the U.S. Food and Drug Administration (FDA) about the recall on Aug. 25, critics say the company was not proactive in notifying consumers about the potential danger. CooperVision posted a recall notice on its website, but did not provide retailers ... Read More