RECALL: Tylenol, Motrin, Benadryl, St. Joseph Aspirin & Rolaids.

[Latina]

Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Rolaids Recall

Information from Industry

January 15, 2010 — Because of a sickening smell in some containers, 54 million packages of 27 different over-the-counter remedies now are being recalled.

Products include various types of child and/or adult Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Rolaids, and Simply Sleep. This adds to the 6 million packages of Tylenol recalled late last year, bringing the total number of recalled products to 60 million.

A musty, moldy odor coming from the products has sickened at least 70 people with nausea, stomach pain, vomiting, and diarrhea.

The FDA says Johnson & Johnson's McNeil Consumer Health Care knew of the problem for more than a year. When the company did act in November and December 2008, it did too little too late, said Deborah M. Autor, director of the FDA's Office of Compliance.


The odor comes from a chemical, 2,4,6-tribromoanisole or TBA. TBA is produced when fungi break down a commonly used fungicide called 2,4,6-tribromophenol. The full health effects of TBA are not known.

Before being filled with product, product containers were stored on wooden pallets apparently treated with the fungicide.

The FDA inspected McNeil's main plant at Las Piedras, Puerto Rico, and was not happy with what it found. The FDA says McNeil began receiving complaints in May 2008, but failed to investigate fully or to warn consumers in a timely manner.

The FDA has given McNeil 15 days to respond to its seven-point warning letter.

Also, the FDA says there are product-quality issues with some Motrin products.

Included in the recall:

Children's Motrin
Children's Tylenol
Extra Strength Tylenol
Regular Strength Tylenol
Tylenol 8 Hour
Tylenol Arthritis
Tylenol PM
Benadryl
Motrin IB
Rolaids
Simply Sleep
St. Joseph Aspirin

A complete list of the recalled products, including package sizes, product types, lot numbers, and UPC codes, can be seen at MCNEIL PRODUCT RECALL. Consumers with question can call McNeil at 888-222-6036.

Consumers who think they may have suffered ill effects from the products should contact the FDA at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

This newsletter can be found, in its entirety, on the FDA website.

[Latina]

MODS:

This is NOT a copy/paste from any website, nor is it the entire letter as posted on any website. This is an FDA newsletter, sent to us as employees of an FDA testing center... so PLEASE do not alter my post!

I just felt it should be posted for all!

[CindyLouWho]

Do you know that if it doesn't have a moldy smell or odor is it okay to use it then? Extra strength Tylenol is the only pain reliever that I'm not allergic to so I'm wondering if I should toss it or not?

[pk]

Do you know that if it doesn't have a moldy smell or odor is it okay to use it then?

I actually had a bottle of the 'moldy' smelling Tylenol for arthritis. I started taking it for a few days but noticed the smell was really bad when you first open the bottle. I had a slight stomach upset right after taking the pills. I spoke to the pharmacy dept at Walmart and they said this only affected the actual bottles that smelled. If in doubt there is a full list that you can check against your lot number on your bottle.

[CindyLouWho]

The bottle I have of Extra Strength Tylenol is on the recall list according to the lot number. It doesn't have any bad odor though. So should I keep it? Or am I supposed to throw it out or return it to the store or what?

BTW...thanks Latina for bringing this to my attention. I hadn't heard anything about it until I saw your post.

[pk]

The bottle I have of Extra Strength Tylenol is on the recall list according to the lot number. It doesn't have any bad odor though. So should I keep it? Or am I supposed to throw it out or return it to the store or what?

Good question Cindy. This may be of interest to those of us that have bottles that need to be returned:



What To Do if You Have a Recalled Tylenol Product
Concerned customers of Tylenol, Motrin, Benadryl, Rolaids, Simply Sleep and St. Joseph's aspirin can find a full list of all the recalled products on McNeilProductRecall.com. McNeil Healthcare will provide information on how to get a replacement for the affect product or a refund. The website was setup after the major recall in January 2010. The McNeil Consumer Care Center can be reached at 888-222-6036.


FULL ARTICLE FOR YOU TO VIEW:
Tylenol Recall 2010

[dgridley]

Thanks for the headsup.. great post, thanks!

Originally Posted by Latina

MODS:

This is NOT a copy/paste from any website, nor is it the entire letter as posted on any website. This is an FDA newsletter, sent to us as employees of an FDA testing center... so PLEASE do not alter my post!

I just felt it should be posted for all!

[Latina]

Originally Posted by CindyLouWho

The bottle I have of Extra Strength Tylenol is on the recall list according to the lot number. It doesn't have any bad odor though. So should I keep it? Or am I supposed to throw it out or return it to the store or what?

BTW...thanks Latina for bringing this to my attention. I hadn't heard anything about it until I saw your post.

I know walmart has been accepting the meds back with full refund or exchange otherwise, as pk said, the phone number might be your best bet to answer that question.

[Latina]

Originally Posted by pk

I actually had a bottle of the 'moldy' smelling Tylenol for arthritis. I started taking it for a few days but noticed the smell was really bad when you first open the bottle. I had a slight stomach upset right after taking the pills. I spoke to the pharmacy dept at Walmart and they said this only affected the actual bottles that smelled. If in doubt there is a full list that you can check against your lot number on your bottle.

We were told (at work) that those who have had stomach upset or other symptoms & seen a Dr for it would have their day. Meaning if you have proof (Dr visits, receipt for the product & such), hold on to that proof. Once this is settled they will be going after the companies involved to reimburse for pain, suffering, work loss, medical bills etc... keep this in mind if you have bad product & suffered due to it.

[pk]

I know walmart has been accepting the meds back with full refund or exchange otherwise, as pk said, the phone number might be your best bet to answer that question.

Walmart told me to bring the meds back in and almost insisted on it. That's when I decided to keep the bottle for awhile. Kinda like evidence if needed.

[Blue Baboon]

Just make sure you place that bottle away from other medicines or mark it as do not use. You wouldn't want anyone to take any by accident.


I wondered about generic or store brand pain relievers. Do the same companies make those?

[pk]

Just make sure you place that bottle away from other medicines or mark it as do not use. You wouldn't want anyone to take any by accident.

No one takes it but me but thanks for the thought, I will mark it just in case.