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Saturday, May 01, 2010

Another Recall for Tylenol and other medicines

UPDATE: 5 May -
FDA found bacteria in lots for recalled Tylenol
By MATTHEW PERRONE, AP Business Writer

WASHINGTON – Ingredients used by Johnson & Johnson in some of the 40 varieties of children's cold medicines recalled last week 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 definitive.

"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 made. The recalled products include children and infant formulations of Tylenol, Motrin, Zyrtec and Benadryl.

FDA inspectors visited the plant in mid-April and wrapped up their inspection Friday. J&J issued its "voluntary" recall later that night.

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" in Tylenol products, according to the FDA's report.

Additionally, inspectors found some pieces of equipment covered with thick layers of dust, while others were held together with duct tape.

In a statement Tuesday, J&J called the problems cited by the FDA "unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate." The health conglomerate, which is based in New Brunswick, N.J., said production at the plant won't resume until the problems have been fixed.

The FDA reiterated that serious medical problems with the products are unlikely, but advised consumers to stop using the medicine as a precaution. Parents are instructed to use generic alternatives instead.

J&J's McNeil Consumer Healthcare unit has said some of the recalled medicines may have a higher concentration of the active ingredient than listed on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet testing requirements.

FDA leadership told reporters Tuesday that they first met with J&J in February to discuss manufacturing problems identified in a warning letter about another J&J plant. The agency decided to step up inspections of the company's facilities based on those problems.

"That warning letter brought us to the point where we thought it was necessary to sit down with management and discuss our concerns," Autor said.

FDA officials said they are considering taking additional action against J&J, ranging from issuing more warning letters to pursuing criminal action.

Last week's sweeping recall, which involved products sold in the U.S. and 11 other countries, is the latest quality issue to taint J&J's over-the-counter medicine franchise. In January, the company recalled a line of adult Tylenol pain relievers due to complaints of a moldy smell associated with wooden pallets used to transport the drugs.

FDA Investigates Recall -WASHINGTON, Saturday May 1 – The Food and Drug Administration said Saturday it was investigating a health-care company for possible other problems following its recall of more than 40 over-the-counter infant's and children's liquid medications.

McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children's Products

Children's cold, allergy medicine recalled

Courtesy: Rense News Network


Anonymous said...

I am ashamed of American mothers for being so negligent in the health of their children. What must be done to get them to take real responsibility for the proper health of their children? Avoiding Oprah, Ellen Degenerate, or Soap Operas would be a great beginning. I see this negligence all the time, and they seem to be getting worse. Do not trust the drug companies, and question everything your doctor does, unless you using a concerned medical professional.

george said...

That is the stupidest comment ive ever read.
u r ashamed of American mothers??
Dont waste your time....
Place blame where blame belongs. On the drug co's and the US Govt. and Governmental agencies.

Anonymous said...

I would like to know more about which Tylenol products contain aspartame/splenda so we can avoid them. Only children's products, or adult products also? I have been taking an adult prescription product that contains name brand Tylenol and I am very concerned. Where is the facility that manufactures adult Rx Tylenol? Is it the same plant as this one? It's very hard to find details... More information please!

Unknown said...

The manufacturer's web site will provide information about regular products as well as child-specific products. It will also have a CONTACT page or other links that will provide their contact information. Ask your question directly of the manufacturer.
And if you take Tylenol or a generic version long term, you may want to try to find out what natural products can provide you with the same impact. In the long run your liver and kidneys will thank you.