May 4th, 2010
07:53 PM ET

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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soundoff (14 Responses)
  1. amanda

    Are there any lot # available or is it to broad of a range?

    May 4, 2010 at 9:49 pm | Report abuse |
  2. natasha

    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??

    May 4, 2010 at 10:15 pm | Report abuse |
  3. Gotkids_01

    cnn seems to be after shock value, not helping consumers with an FDA alert

    May 4, 2010 at 10:16 pm | Report abuse |
  4. Kay

    This website will provide specific information about the children's tylenol recall.

    May 4, 2010 at 10:29 pm | Report abuse |
  5. Darren P

    Why you'd feed your kids Big Pharma's poison anyway is beyond me.

    May 4, 2010 at 11:48 pm | Report abuse |
  6. jb

    same as amanda's question it would be helpful to know the dang lot #s

    May 5, 2010 at 12:11 am | Report abuse |
  7. HernandezUSA

    The more complete list!

    Sounds like a good reason to bring jobs back home where we can keep an eye on the drug companies.

    May 5, 2010 at 12:25 am | Report abuse |
  8. Andrea

    Hernandez – the plant is in much closer to home can it get??

    May 5, 2010 at 6:10 am | Report abuse |
  9. Norah

    Hasn't the FDA since warned us not to use ANY product from this company, suggesting generis instead?

    May 5, 2010 at 12:40 pm | Report abuse |
  10. V

    The website below lists all the products that have been recalled

    May 6, 2010 at 5:28 pm | Report abuse |
  11. CBG

    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 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.

    May 6, 2010 at 8:23 pm | Report abuse |
  12. CCLH

    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?????

    October 18, 2010 at 4:40 pm | Report abuse |
  13. BREL

    CCLH, if you're expecting a refund, don't hold your breath.

    October 20, 2010 at 7:20 pm | Report abuse |