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Children's Tylenol recall: FDA slams factory conditions
A scathing report released Tuesday by the Food and Drug Administration slammed conditions at the factory that produced the children's Tylenol, Motrin, Benadryl and other over-the-counter drugs that were recalled over the weekend.
The 17-page FDA inspection report conducted in late April detailed quality and security lapses at the Fort Washington, PA-based facility, which is owned by Johnson & Johnson's McNeil PPC drug manufacturing division. The agency said it is considering a wide range of actions including possible criminal penalties.
Johnson & Johnson said it has temporarily suspended production at the plant. It is the company's only plant that manufactures all of its liquid pediatric drugs.
"We have no higher concern than providing parents with the highest quality products for their children," the company said in a statement Tuesday. "The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us."
While the FDA said parents should immediately discontinue use of any of the recalled products, the agency maintained that the potential for adverse medical effect from the recalled drugs is still "remote."
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Are there any lot # available or is it to broad of a range?
How could this happen and can it harm my children? Are we to be throwing out our childrens medications? Wat specifically was contaminated... Tylenol... Motrin??
cnn seems to be after shock value, not helping consumers with an FDA alert
This website will provide specific information about the children's tylenol recall.
http://www.tylenol.com/page2.jhtml?id=tylenol/news/ndc_finder.inc
Why you'd feed your kids Big Pharma's poison anyway is beyond me.
same as amanda's question it would be helpful to know the dang lot #s
http://www.mcneilproductrecall.com/page.jhtml?id=/include/mpr_ndc_finder.inc
The more complete list!
Sounds like a good reason to bring jobs back home where we can keep an eye on the drug companies.
Hernandez – the plant is in PA....how much closer to home can it get??
Hasn't the FDA since warned us not to use ANY product from this company, suggesting generis instead?
The website below lists all the products that have been recalled
http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc
I have been reading a number of comments about people whose children had a seizure because they thought that they were treating the fever with Tylenol or Motrin and it never went down. The same thing happened to my daughter this weekend.
If this happened to you the FDA NEEDS to know about this ASAP. Go onto this website http://www.fda.gov/safety/medwatch/default.htm and on the right hand side of the screen you will see a section that states “Report a Serious Medical Problem Product Online”. It only takes a few minutes but this information is critical to the FDA.
I trusted in the medicine I was giving my daughter and as a result of that trust she suffered a seizure and we had to spent hours in the hospital. It was the scariest experience of my life and I want McNeil to own up to their mistake.
Does anyone know how we can actually get a refund for these tainted drugs. Since the April 30th recall, I've completed the online refund form 4 times for the 9 bottles of drugs that I have. 7 are not even opened. Seriously – it's now October. My most recent submission was September 13. Any chance of at least an email response telling us when to expect our refunds?????
CCLH, if you're expecting a refund, don't hold your breath.