Largest OTC medicine recall in history???

[Guest guest]

Poster's Comment: I am told that fungus got into the empty boxes and

bottles, and contaminated the product. Then on top of that, this fungus feeds

off the fungicide they use!

 

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

_http://www.webmd.com/pain-management/news/20100115/tylenol-motrin-benedryl-

rolaids-aspirin-recall_

(http://www.webmd.com/pain-management/news/20100115/tylenol-motrin-benedryl-rola\

ids-aspirin-recall)

 

Containers' Moldy Odor to Blame for Recall of 60 Million Over-the-Counter

Products

By Daniel J. DeNoon

 

 

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 symptoms go away

by themselves and no one has been seriously injured.

 

 

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.

 

 

" When something smells bad, literally or figuratively, companies must

aggressively investigate and take all actions necessary to solve the problem, "

Autor said at a news conference. " McNeil should have acted faster. "

 

 

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. TBA seems to have

infiltrated the product containers before they were filled.

 

 

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. In addition to the contamination issue, the FDA says there are

product-quality issues with some Motrin products.

 

 

Specific products included in the recall include:

 

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

_www.mcneilproductrecall.com_ (http://www.mcneilproductrecall.com) .

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 _www.FDA.gov/medwatch_

(http://www.FDA.gov/medwatch) .