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15 Jan 2011 12:19

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Biz: Johnson & Johnson recalls more drugs over quality issues

  • 47 million more over-the-counter drugs recalled by J&J (wow) source
  • » Why did they recall them? Mainly, there were some quality control issues with the drugs. Johnson & Johnson, which has had to recall a lot of drugs in the last little while due to safety issues, claimed that when researching the prior recalls, they found that manufacturing and safety standards weren’t up to snuff for most of the drugs recalled (Tylenol, Benadryl, Sudafed and Sinutab, which make up about 42.9 million of the 47 million recalled products). The rest of the drugs were insufficiently-labeled packs of Rolaids. J&J has lost hundreds of millions of dollars thanks to the recalls, which first began in late 2009 thanks to some metal specks in children’s medicine.

14 May 2010 15:00

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Biz: So yeah, the plant where Children’s Tylenol was made is a disaster

  • This inspection report is pretty close to being the worst I’ve seen. It suggests that basically the FDA found an issue with almost every system at the plant.
  • Temple University professor (and former Johnson & Johnson employee) David Lebo • Regarding the conditions of a Pennsylvania Tylenol plant that was shut down recently by the Food and Drug Administration. The shutdown followed a mass recall of many children’s drug products by the manufacturer. Nearly three dozen complaints were filed regarding the drugs, which including foreign materials. The FDA’s report suggests that there was lacking quality control that made some of the drugs superpotent (as scary as it sounds). We’re guessing that this PR crisis won’t be fixed as easily as that other one. source

16 Jan 2010 11:20

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Biz: Scary: Lots of big-name drugs getting recalled over “moldy smell”

  • 54M number of packages of over-the-counter drugs that are getting recalled due to a  strange “moldy smell”
  • 27 number of brands – including Tylenol, Motrin, Benadryl and Rolaids – that are getting recalled
  • 70 people have gotten sick as a result of the smell, which causes nausea, vomiting, and other ailments source

01 Jul 2009 11:18

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U.S.: Doctors are split on whether acetaminophen should be banned

  • I do not think eliminating combination products is necessary and that the vote to do so goes too far. Combination products, especially in caring for patients with chronic pain, are important.
  • Ohio State University-based Dr. Randy Wexler • Saying he feels that taking away drugs like Vicodin seems like a step too far. He’s not alone in thinking that, but not every doctor agrees with him. “I think that combo products are generally a bad idea,” said Dr. Elliot Krane of Stanford University. He would’ve liked to see the FDA put further limits on over-the-counter drugs, too. • source

30 Jun 2009 00:56

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Biz, U.S.: Could NyQuil go off the shelves? The FDA’s debating it

Blame a bunch of idiots who OD on acetaminophen. The agent, a key ingredient in Tylenol, causes people to overdose if taken in too high of doses – but those doses aren't far from the labels' recommended doses. Using numbers from a study published in the 1990s, the FDA is trying to ban drugs that mix acetaminophen with other drugs. Like half the cold remedies out there. source

04 Feb 2009 21:55

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U.S.: Authorities prescribe new leads in Tylenol murders

  • What happened? In 1982, a number of bottles of Tylenol were laced with cyanide, killing seven people in Chicago and causing a nationwide recall of the product. The crime was never solved, but its maker, Johnson & Johnson, was able to survive a PR disaster by aggressively recalling the product and creating safer, more secure packaging. (It’s an oft-used example of how to survive a crisis.)
  • Recent developments The FBI searched the Cambridge, Mass. home of James W. Lewis, who sent an extortion letter to the company and was sent to prison. He was never charged in the killings but was always considered a prime suspect. Due to renewed attention after its 25th anniversary, a number of tips led authorities to a major break in the case. source