Get email alerts Get Celiac.com E-mail Alerts  




Celiac.com Sponsor:
Celiac.com Sponsor:




Ads by Google:






   Get email alerts  Subscribe to FREE Celiac.com email alerts

Tylenol, Motrin, Benadryl Factories Taken Over By FDA After Drug Recalls
0

2 posts in this topic

The original date of this thread is March 18, 2011.

Tylenol, Motrin, Benadryl, Rolaids Recall News

Now, the FDA is taking over 3 manufacturing plants operated by Johnson & Johnson McNeil's division, because they have had so many problems with recalls due to slovenly manufacturing processes leading to contamination and mixed up ingredients.

link here: http://money.cnn.com/2011/03/10/news/companies/johnson_mcneil_fda_action/index.htm

McNeil, a division of Johnson & Johnson (JNJ, Fortune 500), said it had agreed to put its plants -- one in Las Piedras, Puerto Rico, one in Fort Washington, Pa. and one in Lancaster, Pa., under FDA supervision.

McNeil's plants in Puerto Rico and Lancaster will continue to operate, McNeil spokeswoman Bonnie Jacobs said. But "there is the potential for some impact [in production] initially as we implement the additional steps."

Stearn said McNeil can continue to manufacture and ship drugs from the Las Piedras and Lancaster plants, but not from the Fort Washington facility.

The agreement also requires McNeil to destroy all drugs under its control that have been recalled from the three facilities since December 2009.

The company shut its Fort Washington plant following a scathing FDA inspection report of the factory last May that cited 20 manufacturing violations.

That facility makes all of McNeil pediatric over-the-counter Tylenol, Benadryl and Motrin medicines. The other two facilities make adult medicines, including Tylenol.

I had noticed that in the past 2 years the list of actual ingredients in over the counter Benadryl products was getting harder and harder to figure out, from the label and not posted on their website, and that the type of packaging and the shape/color of the pills kept changing.

Benadryl is a must - have emergency staple for those people and children with severe allergic reactions, so this was especially troubling. I can't fathom a company selling an allergy medication and not be willing to disclose the ingredients, or worse, having them contaminated with unknowns, it's unethical and disgusting, especially when it's a children's medication. .

Johnson and Johnson's McNeil subsidiary recalled more than 135 million individual packages of children's Benadryl, Tylenol, and Motrin medicines in April of 2010 for possible contamination by bacteria and the presence of small metal parts. In May 2010 it closed the Fort Washington plant in PA that made the children's drugs.

The current agreement with the FDA now says the company can still manufacture and ship drugs from Lancaster PA and Las Piedras Puerto Rico, but not from the Fort Washington PA plant.

The Canadian plant at Guelph was not affected by the agreement.

Recalls:

Late 2009, January 2010, July 2010 - Tylenol, Motrin, Benadryl recalled from Puerto Rican Las Piedras plant over a bad musty smell when the bottles were opened. http://money.cnn.com/2010/12/01/news/companies/tylenol_plant_new_problems/index.htm?iid=EL

In Dec of 2010, Johnson and Johnson McNeil's division recalled 13 million packages of Rolaids Softchews. (Earlier recalls included the tablets) The company subsequently blamed a subcontractor, Best Sweet of North Carolina, a candy manufacturer for the problems which included contamination with foreign particles of metal and wood.

McNeil and the "Phantom Recall" of 2009

http://money.cnn.com/2010/06/02/news/companies/mcneil_motrin_phantom_recall/index.htm

The FDA obtained a memo which was first sent anonymously to Oregon state regulators, which instructed a subcontractor on how to go into stores and quietly buy up batches of the bad product, without arousing any suspicions.

"You should simply 'act' like a regular customer while making these purchases. There must be no mention of this being a recall of the product!" reads the memo dated June 12, 2009.

The FDA could not identify the other companies involved, named in the memo as WIS and CSCS.

The FDA said it was aware that McNeil was using a contractor to remove a sample batch of the product, but not at such a wide scale.

"Once we learned of the contractor's activities, the FDA asked McNeil to initiate a recall, and the company complied," the agency said in a statement.

A list of products that McNeil has recalled in 2010, including pictures of the packages of the Rolaids, St Joseph's baby and adult aspirins, Motrins, Tylenol and Benadryl can be found on their Product Recall Page here, McNeilproductrecall.com :

http://www.mcneilproductrecall.com/page.jhtml?id=/include/prd_all.inc

Is it REALLY too much to ask that when we put a manufactured medication in our mouths, that it is free of contamination, and we have the right to know that the label is accurate, the manufacturer and location is on said label, and all the true ingredients have been listed ?

0

Share this post


Link to post
Share on other sites


Ads by Google:

Thanks for posting about this, I hadn't heard it yet. I don't take Tylenol or Motrin, but I do take Benadryl sometimes. Sounds like it might be safer to a use a generic brand instead.

0

Share this post


Link to post
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!


Register a new account

Sign in

Already have an account? Sign in here.


Sign In Now
0

  • Forum Statistics

    • Total Topics
      104,644
    • Total Posts
      921,579
  • Topics

  • Posts

    • Three years ago I lost about 40kgs (Aussie lol) by better diet & exercise. All was going great til I stopped losing. I upped my exercise but bizarrely started gaining weight. One night a week of not being able to sleep soon became two, then virtually every night with either 1-2hrs tops or none at all. These weird symptoms started about two years ago, becoming worse in say, the last 9mnths. Then I started to get diarrhea. Occasionally then weirdly 2-3 days with multiple occurences then a day or two with nothing, then back to loose & offensive. My GP ran tests, including the TTga (hope that's  right) antibody blood test. Negative so he tells me that's not it. After 9mnths of this he shrugs and says, "I don't know what it is I've run out of ideas what ideas do you have?" Finally refers me to a gastrointerogist.  Private, of course and can't really afford it but we (my fiance and I) go. Stools and blood samples are ordered, basically bye, see you in a month. I have looked my symptoms up and they seem to point to Celiac. Today we went back. I have been having bloated stomach, sore back and limbs,  lovely burps, constant urination and crushing anxiety attacks folowed by depression (which I have never had before in my life). Admitted over the last weekend I didn't sleep for two and a half days and found myself hallucinating and crying to just be able to sleep. Mr fancy pants gastrointerogist says," Hey great news, the stools samples rule out parasites and Crohns!" I tell him how excrutiating the last month has been to which he replies, "It's not Celiac disease, (points at negative blood test results). Celiac doesnt present with diarrhea, anxiety and frquent urination all together." I also had a fecal occult blood test which showed positive & notes say are maybe due to a lower gi bleed, and a ct scan that says shows some damage which, in their words, could be due to a condition such as Celiac disease. He has booked me for a double scope as the next step, has a few ideas what it could be (won't tell me because he doesn't want me to be 'anxious'). Told me to consider that all these symptoms could be me just worrying and being anxious. Told him when this started I was not worried about anything, shrugged and said, It could stil have happened, hey, sometimes we never find out what causes it and your just stuck with diarrhea forever." Then as I was leaving he slapped me on the back and said, "Don't worry so much, see you soon." I need to have the scopes done but is it me or are the things I was told today not true?  I would honestly love it not to be Celiac disease but could he be wrong?
    • Sigh. I totally do love the packs of stretch pants at Costco though...
    • hey, i'm vegetarian and gluten free as well
      have you tried making any recipes with cashew nuts like cashew cheese or pasta sauce? they're really good, easy to make and an excellent way to get more protein/iron
      i can send you some of the easy recipes if you like  
    • Right, fistulas or fissures are usually associated with Crohns, but not celiac.  It is not impossible to have both conditions though.
    • Bravo for being strong enough to bring this topic up.  Depression, anxiety, and other mental or neurological issues are common in celiacs and those with NCGI.  Science is finally catching up to what many of us have already known to be true.   http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3641836/ I have suffered from anxiety and still have some neuropathies.  At first I blamed menopause (that alone can make you crazy), but my symptoms tend kick in after a Gluten exposure and improve as I heal.   You are not crazy!  Gluten can cause so many problems.  What other disease requires that the patient be in charge of "medicating" and caring for themselves?  Most of us after a diagnosis get a "Well, just avoid gluten.  Lucky you that there are so many restaurants that offer a gluten free menu!", speech from our doctors.  We never get time off from thinking about food, our next meal and will it be safe?  Our relationship with food changes dramatically and it can be exhausting.   We do need more resources and support from medical, but for now, at least this forum is helpful!    
  • Upcoming Events

  • Blog Entries

  • Recent Status Updates

  • Who's Online (See full list)

  • Member Statistics

    • Total Members
      61,651
    • Most Online
      3,093

    Newest Member
    Kricket73
    Joined