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FDA Has Issues with Bacterial Found In Tylenol – Risk To Consumers Is Remote But Lab Facilities Are Needed For Testing

Posted May 04 2010 3:14pm

Here’s the link to the original post I made over the weekend that has the links to all the sites where you can go to find out what to take back and in some cases get image your money back too.  The lack of a lab facility is especially bothersome as perhaps any testing may have been outsourced?  I don’t know for sure on that one and it is just a guess on my part, but somebody I think somewhere along the line has to do some testing. 

In the meantime, get some technology going for recalls, I know here we go again, but just my small campaign here showing the need for technology ins this area too.  In 2004 the FDA said they would look into using RFID technology and Tags worth with that too, so where are we six years later – nowhere.  Johnson and Johnson is the “poster child” but this could apply to all device and drug manufacturers.  Eli Lilly was on my hit list too with all their stolen drugs and tags a good way to help find stolen drugs.  I suggested to Baxter on a post yesterday as well with their infusion pumps.  Scan that drug or device with a cell phone, simple process and very easy to use software. 

The say repetition works so I’m giving a real go here to help save lives and improve the current processes or should I say lack of processes and use of technology.

Microsoft Tags on CBS Early Show – Wake Up FDA, Pharma and Medical Device Companies –Scan Those Drugs, Medical Devices and Synchronize with an FDA Tag Data Base – Recalls, Theft Tracking and More….
Tracking Medical Device Recalls – Sounds Like A Good Place for a Microsoft Tag Data Base at the FDA

This is an app just like all others that people install on their phones.  BD

Ingredients used by Johnson & Johnson in some of the 40 varieties of children's cold medicines recalled last Friday were contaminated with bacteria, according to a report by the Food and Drug Administration.

Agency officials said Tuesday none of the company's finished products tested positive for the contaminants, though such testing is not exhaustive.

"We think the risk to consumers at this point is remote," said Deborah Autor, director of FDA's drug compliance office, on a call with reporters.

The FDA report, which was posted online, lists more than 20 manufacturing problems found at the McNeil Consumer Healthcare plant in Fort Washington, Pa., where the formulas were produced. The recalled products include children and infant formulations of Tylenol, Motrin, Zyrtec and Benadryl.

Among other problems, FDA inspectors said the company did not have laboratory facilities to test drug ingredients and failed to follow up on customer complaints.

J&J did not investigate more than 46 complaints received in the last year about "black or dark specks" found in Tylenol products, according to the FDA's report.

In a statement Tuesday, J&J called the problems discovered by the FDA "unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate." The company said production at the Fort Washington plant won't resume until corrective measures have been put in place

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