Nursefriendly.com: drug recalls

Showing posts with label drug recalls. Show all posts

Friday, March 11, 2011

FDA takes over Johnson & Johnson's Tylenol plants - Mar. 10, 2011

The government is taking over three Tylenol plants following a blizzard of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.
The FDA and the Justice Department on Thursday took action against McNeil PPC and two of its executives -- its vice president of quality and its vice president of operations for over-the-counter products -- for failing to comply with federally-mandated manufacturing practice.

McNeil, a division of Johnson & Johnson (JNJ, Fortune 500), said it had agreed to put its plants -- one in Las Piedras, Puerto Rico, one in Fort Washington, Pa. and one in Lancaster, Pa., under FDA supervision.

The agreement, known as a "consent decree," is subject to approval by a federal judge in Pennsylvania.

via money.cnn.com

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Saturday, January 15, 2011

Oregon sues Johnson & Johnson over "phantom" Motrin - Jan. 13, 2011

Oregon has sued Johnson & Johnson for allegedly selling defective Motrin drugs to consumers in the state for more than a year, and for trying to secretly remove the faulty drugs from stores.
"Companies that break the rules and put consumers at risk will be held accountable," Oregon Attorney General John Kroger said in a statement.

The state filed the lawsuit Wednesday against J&J (JNJ, Fortune 500) and its two subsidiaries, McNeil PPC Inc. and McNeil Healthcare Inc. The company's McNeil division makes over-the-counter cold and pain drugs such as Tylenol, Motrin and Benadryl.

The suit claims that J&J discovered in late 2008 that some supplies of Motrin sold in gas stations and convenience stores nationwide were defective because they were not properly dissolving.

via money.cnn.com

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Monday, January 3, 2011

New Drug Approvals Slipped in 2010 - WSJ.com

The Food and Drug Administration approved about 21 drugs in 2010, a relatively modest figure that shows the pharmaceutical industry hasn't yet escaped its drought in recent years.

A few potential blockbusters won approval during the year, but some of the most highly anticipated new products got delayed into next year or beyond. That partly reflects a tougher environment at the FDA, with regulators stepping up their scrutiny of safety issues in drugs for obesity, diabetes and other conditions.

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According to monthly drug-approval reports on the FDA's website, 21 new drugs were approved in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007.

The final approval figures, as well as the number of applications received by the agency in 2010, won't be available until next month. The approval figures don't include dozens of approvals granted for new formulations or new uses of existing drugs.

Although the 2010 figures are a bit lower than previous years, FDA spokeswoman Sandy Walsh said there's "no systemic change in how the FDA is approaching drug approvals."

The figures include several major biologic drugs, which are created from living cells and represent a growing portion of the pharmaceutical market. Amgen Inc. won approval for Prolia, a drug that is injected twice yearly to treat osteoporosis in postmenopausal women. Roche Holding AG's biotechnology unit, Genentech, won approval for Actemra, a drug that's administered intravenously to treat rheumatoid arthritis.

via online.wsj.com

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Sunday, January 2, 2011

Drug recalls surge to more than 1,700 in 2009 - Aug. 16, 2010

Recalls of prescription and over the counter drugs are surging, raising questions about the quality of drug manufacturing in the United States.
The Food and Drug Administration reported more than 1,742 recalls last year, skyrocketing from 426 in 2008, according to the Gold Sheet, a trade publication on drug quality that analyzes FDA data.

One company, drug repackager Advantage Dose, accounted for more than 1,000 of those recalls. Even excluding Advantage Dose, which has shut down, recalls jumped 50% last year.

"We've seen a trend where the last four years are among the top five for the most number of drug recalls since we began tallying recalls in 1988," said Bowman Cox, managing editor of the Gold Sheet. "That's a meaningful development."

The fast pace of drug recalls seems to be continuing in 2010. Drug recalls totaled 296 from January through June of this year, said Cox. "If we continue at this same rate, we could get 600 or more recalls by the end of the year," he said. "That's still a very high rate of recalls."

via money.cnn.com

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Friday, March 11, 2011

FDA takes over Johnson & Johnson's Tylenol plants - Mar. 10, 2011

Saturday, January 15, 2011

Oregon sues Johnson & Johnson over "phantom" Motrin - Jan. 13, 2011

Monday, January 3, 2011

New Drug Approvals Slipped in 2010 - WSJ.com

Sunday, January 2, 2011

Drug recalls surge to more than 1,700 in 2009 - Aug. 16, 2010

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