Millions of bottles of the pain reliever acetaminophen are being recalled because they may contain metal fragments.

The recall affects 11 million bottles containing varying quantities of 500-milligram acetaminophen caplets made by the Perrigo Co. The pills were sold under store brands by Wal-Mart, CVS, Safeway and more than 120 other major retailers, the Food and Drug Administration said, some as long ago as three years. At least two chains - CVS Corp. and SuperValu Inc. started pulling the pills from store shelves Thursday.

According to the FDA, the pills included metal fragments (though the type of metal has yet to be determined),ranging in size from microdots to portions of wire one-third of an inch long.

The discovery was made during quality-control checks done after the company Perrigo, discovered its equipment was wearing down prematurely, the FDA said. Agency officials declined to say whether the metal found in the pills caused the damage or resulted from it.

According to the FDA, a company investigation turned up metal in about 200 of the 70 million pills it passed through a metal detector.

Consumers who take any of the contaminated pills could have minor stomach discomfort or possible cuts to the mouth and throat, the FDA said, adding that the risk of serious injury was remote, and as of yet there has been no immediate reports of ilness.

Acetaminophen is best known as the drug in products sold under the Tylenol brand, but it is available in typically less expensive generic versions. Acetaminophen along with aspirin and ibuprofen, is one of the most popular pain relievers available over the counter.

The recall does not affect Tylenol. Nor should the recall cause a shortage of acetaminophen, the FDA said.

Perrigo says it is the world's largest manufacturer of store-brand nonprescription drugs. The retail market for the pain relievers is worth more than $2 billion a year.

Kevin Vincent, 44, of Arlington, Va., said "If it's not something that has any chance of recurring, then I really wouldn't worry."

The 129 retailers that could potentially be affected by the recall include Wal-Mart Stores Inc. CVS, Safeway Stores and SuperValu as they sell the Perrigo-made pills under their own or other private labels.

CVS will stop selling its own brand of 500-milligram acetaminophen caplets and pull bottles from store shelves nationwide. SuperValu also began removing the pills from its Albertsons, Cub Foods and other stores, according to their spokespersons.

Molly Walsh, 21, a George Washington University student shopping at a CVS pharmacy in Washington, said she did not plan to toss any of the store-brand drugs at home, "It's still going to be cheaper and I'm still going to be broke after the recall."

The FDA did not know in which states the pills had been sold, but recommended that customers determine whether products they bought are being recalled by checking the store list on the FDA Web site, and the batch list. The batch numbers appear on the container's label.

It has not been determined where Perrigo made the pills. Its main factories are in the United States and Israel, with secondary plants in the United Kingdom, Mexico, Germany and China.

According to FDA records, Perrigo has carried out at least 32 other product recalls since 1993, as recently as May when it recalled nearly 59,000 bottles of a 500-milligram combination pain-reliever and sleep aid that contains acetaminophen because of contamination with acrylic mirror particles.

NEW YORK -- The American Civil Liberties Union today applauded Donald Rumsfeld's resignation from his post as Defense Secretary, and called on Congress to investigate the gross abuse of power committed under his watch.

"Donald Rumsfeld's resignation is a step in the right direction," said Anthony D. Romero, ACLU Executive Director. "Rumsfeld is responsible for the torture and abuse of detainees in U. S. military custody and must be held accountable for the failures that occurred on his watch. He has placed the blame on junior military members and has been nothing but derelict in his duty. Congress must initiate an immediate and exhaustive investigation into his six-year-long record of unlawful activity, violations of the rule of law and complicity in the executive branch abuse of power."

As a result of the ACLU's Freedom of Information Act lawsuit, more than 100,000 pages of government documents have been released detailing the torture and abuse of detainees in Iraq, Afghanistan and Guantánamo Bay. In March 2005, the ACLU and Human Rights First filed the first federal lawsuit naming Rumsfeld and other top U.S. officials in the ongoing torture scandal in Iraq and Afghanistan that has tarnished America's reputation. A hearing in that case, Ali v. Rumsfeld, is scheduled for December 8. In June 2006, the Supreme Court in Hamdan v. Rumsfeld ruled that the Bush administration policy on detention, orchestrated by Rumsfeld, was illegal.

The ACLU has also filed a lawsuit to uncover details of Pentagon surveillance of peace groups and law-abiding Americans who have attended anti-war protests. The documents obtained by the ACLU reveal that the Pentagon shared information on activists with other government agencies through the Threat and Local Observation Notice (TALON) database, which was intended to track groups or individuals with links to terrorism.

WASHINGTON – (USDOJ) Attorney General Alberto R. Gonzales announced on Monday that the United States signed an Executive Agreement with Eurojust, the judicial cooperation unit of the European Union (E.U.), which will improve transatlantic law enforcement coordination and enhance the ability of the U.S. and the E.U. to fight international crime. The Agreement will foster the exchange of information between law enforcement communities in the U.S. and the E.U. and will strengthen cooperative efforts to prevent and prosecute organized crime, human trafficking, cybercrime and terrorism.

Specifically, the agreement establishes the position of U.S. Liaison Prosecutor to Eurojust. The Liaison Prosecutor will be based at Eurojust headquarters in The Hague, Netherlands, and will facilitate law enforcement cooperation between the U.S. and the E.U. on a day-to-day basis. The Agreement particularly ensures the protection of personal information and individual privacy for both citizens of the U.S. and the E.U.

"This agreement is just one more example of the strong relationship that exists between the United States and the European Union on law enforcement issues," said Attorney General Gonzales. "It represents an important part of our ongoing efforts to combat transnational crime and international terrorism while protecting the civil liberties of our citizens."

The Executive Agreement was signed following troika meetings hosted by Attorney General Gonzales at the Department of Justice with Secretary of Homeland Security Michael Chertoff, Minister of Justice of Finland Leena Luhtanen, Minister of Interior of Finland Kari Rajamaki and Vice President of the European Commission Franco Frattini.

(VOA) - The Democratic Party appears to have regained control of both houses of the U.S. Congress from President Bush's Republican Party.

American media reports say that challenger Jim Webb has defeated Republican incumbent George Allen in the Senate race in the U.S. state of Virginia. It is the last Senate race from Tuesday's mid-term elections to be decided.

Allen has not yet conceded defeat, but major newspapers and television networks report that Webb holds more than a 7,000 vote lead.

Opposition Democrats have already swept to victory in the U.S. House of Representatives. Projections show that the party holds a majority of 229 seats in the 435-seat chamber.

If Webb indeed wins in Virginia, Democrats and Republicans will each hold 49 of the Senate's 100 seats. Two independents, Joe Lieberman of Connecticut and Bernie Sanders of Vermont, have pledged to vote with the Democrats, tipping the balance in the Senate to Democratic Party control.

The Democratic Party victory comes on the back of voter frustration with the war in Iraq and several political scandals. And it sets the stage for a number of policy battles with the White House. The Democrats have not controlled both chambers of Congress in 12 years.

President Bush has expressed disappointment with the election results, but he called on both political parties to work together. He is meeting separately Thursday, with Republican and Democratic congressional leaders.

Opinion polls showed that dissatisfaction with President Bush and his handling of the Iraq war drove many voters to vote for Democrats.

Meanwhile, California Democrat Nancy Pelosi is poised to become the first female Speaker of the House. She has pledged to work with congressional Republicans.

Senate Democratic leader Harry Reid of the U.S. state of Nevada said the message from the electorate was clear, and that Americans voted for change.

WASHINGTON — Personal exemptions and standard deductions will rise, tax brackets will widen and income limits for IRAs will increase in 2007, thanks to inflation adjustments announced today by the Internal Revenue Service.

By law, the dollar amounts for a variety of tax provisions must be revised each year to keep pace with inflation. As a result, more than three dozen tax benefits, affecting virtually every taxpayer, are being adjusted for 2007. Key changes affecting 2007 returns, filed by most taxpayers in early 2008, include the following:

• The value of each personal and dependency exemption, available to most taxpayers, will be $3,400, up $100 from 2006.
• The new standard deduction will be $10,700 for married couples filing a joint return (up $400), $5,350 for singles and married individuals filing separately (up $200) and $7,850 for heads of household (up $300). Nearly two out of three taxpayers take the standard deduction, rather than itemizing deductions, such as mortgage interest, charitable contributions and state and local taxes.
• Tax-bracket thresholds will increase for each filing status. For a married couple filing a joint return, for example, the taxable-income threshold separating the 15-percent bracket from the 25-percent bracket will be $63,700, up from $61,300 in 2006.

In 2007, for the first time, inflation adjustments will raise the income limits that apply to the retirement savings contributions credit, contributions to a Roth IRA and deductible contributions to a traditional IRA where the taxpayer or the taxpayer’s spouse is covered by a retirement plan at work.  

(FDA) - The U.S. Food and Drug Administration (FDA) today announced its action plan for strengthening the way it monitors the safety of medical devices after they reach the marketplace.

"Many of today's medical devices are smaller and more complex than ever, offering new medical opportunities that have benefited literally millions of people," said Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs, FDA. "But this technical sophistication sometimes means that the margin for error with device manufacturing shrinks and so we need to be working even harder, after devices and engineering changes are approved, to monitor for potential safety problems."

FDA's Center for Devices and Radiological Health (CDRH) last year completed a comprehensive assessment of the tools used to monitor the safety of medical devices after the agency approves them for marketing. In January, the agency formed a Postmarket Transformation Leadership Team to develop an action plan focusing on four main areas: enhancing the center's culture of collaboration; developing world class data systems; enhancing risk/benefit communication efforts; and collaborating on improved enforcement strategies and outcomes.

"The agency is committed to improving its medical device safety program and ensuring that medical devices and radiation-emitting products remain safe and effective once they are in the hands of health professionals and the public," said Daniel Schultz, M.D., Director, CDRH. "Postmarket systems that enable constant learning and feedback not only help support best medical practices to ensure safe use of devices with maximum effectiveness but they also spur continued innovation. This plan is a major step in that direction."

Today's Postmarket Transformation Leadership Team report outlines actions to transform the postmarket program. These efforts will increase the agency's ability to identify, analyze, and act on the risks that may be posed by the thousands of devices used by health professionals and consumers every day. The action items include the following:

• creating a cross-cutting organizational structure within CDRH to better integrate premarket, postmarket and enforcement efforts;
• developing internal performance measurements to track the center's handling of postmarket issues, such as recalls;
• pursuing the development of a unique identifier system to identify a device and the information associated with that device throughout its lifetime;
• proposing mandatory use of electronic reporting for required adverse event reports and revising the current system that records reported adverse events for devices (the Manufacturer and User Facility Device Experience Database or MAUDE system);
• increasing the use of Medical Product Safety Device Network (MedSun) programs—a network comprised of more than 350 hospitals that have been recruited and specifically trained to identify and report device problems, and help provide "real time" data on signals and safety problems;
• enhancing risk/benefit communication efforts so health practitioners, patients and consumers receive clearer and more timely information on public health news; and
• increasing the coordination among the agency's compliance and enforcement programs.

The world's third largest publicly traded oil company BP Plc, agreed to settle a lawsuit brought by a woman whose parents died in a Texas refinery explosion, woman's lawyer said.

Though the terms of the agreement were confidential, BP set aside $1.6 billion to resolve the claims.

The London based BP, has acknowledged safety shortcomings at the plant, and settled about 1,000 suits, including all death claims except the two filed by Eva Rowe, 22. She lost both her parents in the explosion and has refused to settle unless BP agrees to change safety procedures and equipment.

Roddy Kennedy, who heads BP's press office in London, said he couldn't comment on the reported settlement. BP will pay money to community groups as part of the settlement, attorney Brent Coon said.

If if the trial had gone forward, BP faced unlimited damages and harm to its reputation. The March 23, 2005, explosion killed 15 and injured hundreds at its Texas City, Texas, refinery led to more than 1,300 suits against BP, a record fine from the U.S. Occupational Safety and Health Administration and a finding by another safety agency that the company endangered workers by cutting costs.

The evidence to be introduced, including an internal study showing the company ignored safety problems at the Texas City refinery, could have produced sizable punitive damages. The trial was set to begin with jury selection today.

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Sheryl Jones
Staff Writer