FDA: McNeil Plant That Made Recalled Tylenol Is A Dirty Stinkpot With No Quality Control

One of the implied promises of a brand name, especially when it comes to drugs, is you can expect higher quality, but maybe that doesn’t apply when it comes to McNeil products.The FDA says the plant that produced the recently recalled children’s Tylenol, Motrin, Zyrtec and Benadryl, was using raw materials that were contaminated with bacteria. The plant also lacked adequate quality-control procedures and was dirty. So far none of the recalled medicine has tested positive for bacterial contamination, but the FDA report suggests that the contaminated material was used to make the recalled lots. The plant has been shut down indefinitely.

McNeil Consumer Healthcare and the FDA both insist that despite the crappy quality of the plant and the products it produced, there is very little risk of illness from any of the recalled drugs.

But as several consumer advocates and health experts point out to ABC News, the real issue is that brand name drugs are just as susceptible to shoddy manufacturing practices as generics. In particular, McNeil has issued three recalls in less than a year for problems with their drugs; the last one was the bad-smelling Tylenol Arthritis product back in December and January.

Johnson & Johnson is acting all “Oh we’re just as shocked as you folks” about it:

Johnson and Johnson issued a statement Tuesday in response to the report.

“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, and not indicative of how McNeil Consumer Healthcare intends to operate,” the Johnson and Johnson statement read.

Until McNeil operates as J&J intends, you can just use generic equivalents and bypass their branded products. You’ll save money, and you might even get a higher-quality product.

“Children’s Tylenol Recall: FDA Report Rips Quality Control at Plant” [ABC News]

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  1. nbs2 says:

    Can someone point me to a generic dye free children’s Benadryl?

  2. dulcinea47 says:

    I think I was born without whatever gene makes people think branded OTC medication is better…. the generic is the same thing, you’re just not paying for lots of ads and fancy packaging. I know some people claim the brand names work better but I question whether that’s all in their heads.

    • chrisexv6 says:

      I was born with the same gene, maybe we’re family!

      I think the biggest crock of all are the infant meds. You get a tiny bottle that barely lasts for one cold and they charge you twice as much. Thats when I started on store brand stuff (CareOne from Stop and Shop gets my thumbs up) and Ive never looked back. Saved a ton of $$$ and the products work really well.

      Last time I went to get Tylenol (generic) I had a laugh that all the actual name brand Tylenol had been recalled but the store brand stuff was all stocked up.

      • nbs2 says:

        If you look at infants vs children’s tylenol/motrin, there is a huge difference in cost per dose of active ingredient. When I noticed that I realized I could give the kid the children’s product instead of the infant’s, and save both time and money (fewer trips to replenish supplies and lower cost) as long as I was careful not to give her more than the recommended dose. And with the “thinner” children’s product, the risk of overdosing when delivering tiny quantities of drug were even lower. I broached the issue with our daughter’s pediatrician, she just smiled.

        • chrisexv6 says:

          I thought about that too. If it were just me dosing my kids I would have gone for it. I worry when they are home and the wife and I are at work and whoever is watching them needs to give them meds. What happens if they forget a “mundane detail” like a decimal place (Office Space FTW!) and give the kid much more than they should.

          Luckily our infant is close to childrens med age/weight so it will soon be a non-issue.

    • Baccus83 says:

      Technically, what you’ll hear is that while the active ingredients are the same, some the inactive ingredients may be different. For example, Benadryl and WallDryl will contain the same stuff that treats your symptoms, but only Benadryl has a release mechanism that makes it work faster and more efficiently than the generic version. I don’t know if there’s really any truth to this – but it’s just something to consider.

      • webweazel says:

        Everybody here states the truth. Generics or store brands that have a listed ACTIVE ingredient are legally required to be the same as the name brand. INACTIVE ingredients can vary. So, yes, a name brand may have a special INactive ingredient to make the meds work better. One can only try different ones to find what works and what doesn’t for them. (Buy small bottles/amounts in the beginning.)

        As a side note, this is also a way to price compare on other over-the-counter medications, pesticides, cleaners, and other items of this sort. If they MUST disclose and ACTIVE ingredient, you can compare labels to find out if they’re an exact match, then check the price. It’s an AWESOME way to save money.

        For example, I recently compared Claritin to store brand. Same active ingredients, same strength. Claritin is almost $1 per pill. I bought the store brand, 30 pills for $6. (Saved $24) Years back, I was looking for something for diaper rash. Checked out the diaper salves, all around $5-10 for a tiny jar or tube, found the active, Zinc Oxide, and found a tube of plain Zinc Oxide for $1. Worked great. (Saved $4-9)

        It all adds up to hundreds of dollars saved every year!

    • hbar says:

      Oftentimes they do have the same effects, so it’s worth trying out some generics. That being said, I asked my dad — a neurologist — about the difference between brand names and generics. He told me that generics are required to legally be equivalent to brand names — but within a certain margin of error. In essence, generics are not required to have the same consistency (in terms of the amount of each chemical) as brand names.

      And — sorry, this is nitpicking — when you pay more for brand names, you are paying for the years of research put into it that generics did not have to go through. You’re right, though, sometimes the price differences are quite astonishing.

    • P=mv says:

      It depends on the person. I know several people that cannot take generic Rx painkillers. They could take the whole bottle and it has less effect than one name-brand.

  3. humphrmi says:

    Are we sure that the generics aren’t made in the same plant?

    • Kitamura says:

      That’s what I’m thinking, though I know a few people who can’t take a few generics because they’re allergic to one of the inactive ingredients in the generic that must use as filler that the brand name doesn’t.

      Still given how much we hear about generic product X being made in the same place as brand name Y, I wouldn’t be surprised if tomorrow we hear about all these generics being recalled for the exact same reason.

  4. fsnuffer says:

    Every manager at that plant should be forced to take a dose of Tylenol and Motrin that came off their line.

  5. CrazyJaney says:

    I can’t help thinking about the cold my daughter had that kept coming back and back for over a month. They tested for strep and mono but perhaps we should have been looking at the cold medicine instead. She wasn’t taking any of these recalled medicines but still, there’s no real reason to simply assume this isn’t more of a wide-spread problem.

    • chrisexv6 says:

      I had a cold like that. In my case I dont think it was the meds I think it was just a bad cold season this winter.

      I think the best thing for it was a humidifier and lots and lots of clear liquids.

      • CrazyJaney says:

        We used something called SinuCleanse, a pretty effectively designed saline solution squirt bottle. It was quite disgusting but it helped her sleep at night. I knew it was helping because she kept asking if she could do it again.

    • Dont lump me into your 99%! says:

      Our son was like that, and we were giving him the now recalled Tylenol. Its insanity!

    • Mr. Fix-It says: "Canadian Bacon is best bacon!" says:

      I had this same problem. After about 2 weeks, I basically said “Alright, to hell with this. I’m going to the doc and get this sorted out once and for all.” One chest X-Ray later, and it turned out to have developed into fungal pneumonia.

      I had to take these scary prescription horse-pills for a week to get rid of it.

      Maybe not quite as related, but even still, it makes you think, right?

  6. Pinget says:

    How bad can this bacteria be that they won’t even disclose what it is? The silence is disturbing.

  7. sopmodm14 says:

    i’ll bet the fine is only a fraction of the profits

    if the fine is more than a slap on the wrist, we all wouln’d be in jeopardy of our health

  8. There's room to move as a fry cook says:

    According to some-expert-on-CNN – most ingredients come from overseas – mixing, formulating & packaging are done in the states.

  9. PupJet says:

    The only product I took for my cold [I believe] wasn’t recalled. I took the Tylenol Warming Liquid. Granted it tastes worse than most things I would even contemplate consuming, it did the trick. It also had a nice little effect of knocking my ass out, which helped with my other medication that gives me insomnia. :P

    • mbz32190 says:

      No generic versions of these seem to be recalled, so they must be made by someone else. (Usually generics have minor changes in inactive ingredients)

  10. Hackoff says:

    Well I gave both Motrin and Tylenol to my 2 year old who had a fever of 103 for nearly 5 days. A visit to the Dr. and a urine test showed that she had a bacterial infection of the e.coli strain. I know it is paranoia to think that the Tylenol and/or Motrin could have caused the secondary bacterial infection, but it makes me wonder. And, yes both of the bottles have the lot/batch number that is part of the recall.

  11. bri says:

    As an engineer having worked in manufacturing this just completely boggles the mind. For starters the factory should have been ISO certified which means yearly checks just to maintain that certification. Second, the company itself should be doing audits on its own because you are dealing with things people ingest, i.e., could potentially kill someone. This is pure and simple incompetence and laziness. These people should in jail, not fined!