FDA Slams Tylenol Maker's Delay in Tainted Pill Recall (more products added-I have one)

ABC News ^ | 1-15-10 | Joseph Brownstein

[STARWISE]

More Products, Including Tylenol Extra Strength and Rolaids, Recalled Due to Noxious Chemical Fears

###

The U.S. Food and Drug Administration slammed Tylenol manufacturer McNeil Healthcare LLC during a media briefing this morning for what it called a slow response to problems at a facility in Puerto Rico that led to consumers becoming sickened by tainted pills.

"McNeil should have acted faster," said Deborah Autor, director of the FDA's Office of Compliance, of the arm of Johnson & Johnson that manufactures Tylenol products, adding "When something smells bad, literally or figuratively, they must aggressively investigate and solve the problem."

A recall of Tylenol products that began last month with the popular Tylenol arthritis caplet expanded this morning to include more than two dozen other over-the-counter products manufactured by McNeil.

LIST OF RECALLED ITEMS

[STARWISE]

***LIST OF RECALLED ITEMS:

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

~~~~~~~~~~~~~~

More on the recall:

**NOTE: I thought Motrin was in the copy I first
saw, but then when I went to the site, it was not
shown amongst the products, so I didn’t include it
in the original post.

Now MOTRIN IS named again, so I feel confident it
IS on the recall list.

CHECK YOUR BOTTLE LOT #’S .. I have one that I
purchased over 6 months ago.

~~~~~~~~~~~~~~~~~~~

Johnson & Johnson issued a massive recall Friday of over-the-counter drugs including Tylenol, Motrin and St. Joseph’s aspirin because of a moldy smell that has made people sick.

It was the second such recall in less than a month because of the smell, which regulators said was first reported to McNeil in 2008. Federal regulators criticized the company, saying it didn’t respond to the complaints quickly enough, wasn’t thorough in how it handled the problem and didn’t inform the Food and Drug Administration quickly.

The recall includes some batches of regular and extra-strength Tylenol, children’s Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children’s Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, and St. Joseph’s aspirin.

http://news.yahoo.com/s/ap/20100116/ap_on_bi_ge/us_johnson___johnson_tylenol_recall

~~~~~~~~~~

In its statement, the company advised consumers who purchased the affected products to stop using them and contact McNeil for information about how to get a refund or a replacement.

The company provided the address for its Web site,

http://www.mcneilproductrecall.com, as well as a toll-free number:

(888) 222-6036.

_________________________________

I just called them ... I did a #67 to block my number,
followed the prompts to receive a coupon, choose my
product, punched in the lot # and exp date, got the
confirmation it was on the recall list, and spoke the
description and size of the bottle.

You’re asked to either let them use the public info for
your address or say the address, which I did. Your info
is played back for confirmation, and you’re told you’ll
receive a coupon in 3 to 4 weeks.

So, it appears to be a straightforward process.

[Vendome]

Well that’s great. Now I have to go dumpster diving and get the stuff I tossed last night.

Good to see they are making good on their mistake.

[greyfoxx39]

What about the generics?

[E.G.C.]

BTTT

[GoRepGo]

I feel your pain. I have a huge bottle of Motrin that is on the list. They offer a replacement coupon but I want a refund.

Homeopathics here I come.

[STARWISE]

This recall is from Johnson & Johnson’s
McNeil Healthcare LLC, the manufacturer
of Tylenol and the other list of products,
which were apparently manufactured in
Puerto Rico.

[STARWISE]

Okay!

[greyfoxx39]

I read the links. Just wondering if any of the generic products for Tylenol were made in the same plant and branded differently. I haven’t seen any indication of this yet. I use the generic acetaminophen daily.

[NormsRevenge]

Thanks for that info. We have Tylenol to swapout here, not sure if the Rolaids was bad.. it worked. :-)

[STARWISE]

The IMPORTANT issue is the Lot # .. be
sure to check out your particular item
against their list.

It may end your heartburn, but could give
you another problem, if it’s contaminated.

[calex59]

The earlier report, which was posted here on FR, said that the cause of the smell was mold. They left the packages that they packed the products in setting on wet pallets, this caused mold to grow on the packages which in turn showed up later on(I presume on because I don’t see how mold go inside the packages)the bottles of medication. This caused the symptoms which were described as mild(by the FDA)and non life threatening. Whether they were telling the truth of not is anyone’s guess. For what it’s worth I have a package of Tylenol Arthritis tablets that has one of the lot numbers on it, I had taken about half of it before the recall came out. It does not smell and did not make me sick. None the less, I quit taking them. I would guess from this that not all of the products were affected by this “mold”.

[Vendome]

I cannot believe this crap. I have 5 bottles of their stuff, two of which(rolaids) had made my stomach worse. I used another product on top of that.

Benadryl and Tylenol are on the list of course and I am sitting here trying to remember if there are more somewhere else, like my house.

That’s fifty bucks of their stuff all bought at different times that are recalled.

These guys need to pay and it should be enough that it is seared into their memory, not to every do it again.

I still have friends who won’t touch Tylenol after the 1980’s incidents.

[patriciaruth]

The Tylenol 8hr that I just sent the troops is from lot PPM054. Expire 9/10

They were a couple of travel size bottles of 24 in boxes attached as bonus caplets to the boxes with bottles of 100 pills that I bought a while ago.

I’d appreciate a heads up if you find these are a problem. I’ve already used over half the pills in one of the bottles and didn’t notice any odor (I’ve got a good nose). I often don’t feel well so that is not necessarily an indication of a problem with the pills. I generally take one a night.

Are any of the generic meds involved in this recall. I’ve got generic acetaminophen (Tylenol) and generic diphenhydramine (Benadryl)?

[STARWISE]

These are all from the McNeil division of Johnson & Johnson .. no generics I’ve heard.

~~~

This is not on the list

**The Tylenol 8hr that I just sent the troops is from lot PPM054. Expire 9/10

~~~

Their website has the phone #;

https://www.mcneilproductrecall.com/index.jhtml

I’d call them about these:

**They were a couple of travel size bottles of 24 in boxes attached as bonus caplets to the boxes with bottles of 100 pills that I bought a while ago.

[hennie pennie]

*ping*

[hennie pennie]

Does the FDA have a webpage devoted to this massive recall?

I don't like the idea of relying upon McNeill's website for accurate information. For instance, on the top of the page linked to in the article, it is stating all the children's brands -- I wanted to learn about the Benadryl -- OR is this still only the kid's version??

Surely the FDA must have an updated version of this recall with complete information???

Thank you.

[STARWISE]

Go to ALL recalled products on top

http://www.mcneilproductrecall.com/#

[hennie pennie]

Thanks, but I don't want to go to the McNeil website, I don't trust them and I don't trust Johnson & Johnson --- I'll try to locate info about this recall at the FDA website, maybe they have a list.

But thank you, Starwise.

[STARWISE]

Well, FDA obviously gets their #’s from the manufacturer.

FDA

http://www.fda.gov/downloads/Safety/Recalls/UCM197769.pdf

[hennie pennie]

I want the FDA to get my hits, and to realize that I am very interested in this massive recall. I don't trust McNeil, so I don't want to use their website.

Thank you for all your assistance today, Starwise -- not one of my friends knew ANYTHING about this.