Fw: Tylenol Recall

[Guest guest]

Just wonderful... when was first diagnosed with the Lyme. I had to get

him 650 mg tylenol 8 hr...lot # AEM087. He ended up in hosp. for IV treatment

from the uncontrollable vomiting.... Now I wonder. I still have some here.

Check this out...

 

 

Fort Washington, PA (January 15, 2010) In consultation with the U.S. Food and

Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC,

Inc., is voluntarily recalling certain lots of OTC products in the Americas, the

United Arab Emirates (UAE), and Fiji (FULL RECALLED PRODUCT LIST BELOW). The

company is initiating this recall following an investigation of consumer reports

of an unusual moldy, musty, or mildew-like odor that, in a small number of

cases, was associated with temporary and non-serious gastrointestinal events.

These include nausea, stomach pain, vomiting, or diarrhea. This precautionary

action is voluntary and has been taken in consultation with the FDA.

Based on this investigation, McNeil Consumer Healthcare has determined that the

reported uncharacteristic smell is caused by the presence of trace amounts of a

chemical called 2,4,6-tribromoanisole (TBA). This can result from the breakdown

of a chemical that is sometimes applied to wood that is used to build wood

pallets that transport and store product packaging materials. The health effects

of this chemical have not been well studied but no serious events have been

documented in the medical literature. A small number of the product lots being

recalled were associated with the complaints of an unusual moldy, musty, or

mildew-like odor, and some of these lots were found to contain trace amounts of

TBA. In December 2009, McNeil Consumer Healthcare also recalled all lots of

TYLENOL® Arthritis Pain 100 count with EZ-OPEN CAP related to this issue.

McNeil Consumer Healthcare has now applied broader criteria to identify and

remove all product lots that it

believes may have the potential to be affected, even if they have not been the

subject of consumer complaints.

In addition to the product recall, McNeil Consumer Healthcare is continuing

their investigation into this issue and is taking further actions that include

ceasing shipment of products produced using materials shipped on these wood

pallets and requiring suppliers who ship materials to our plants to discontinue

the use of these pallets. We will continue to closely monitor and evaluate the

situation and consult with the FDA.

Consumers who purchased product from the lots included in this recall should

stop using the product and contact McNeil Consumer Healthcare for instructions

on a refund or replacement. For these instructions or information regarding how

to return or dispose of the product, consumers should log on to the internet at

www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10

p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Consumers

who have medical concerns or questions should contact their healthcare provider.

Any adverse reactions may also be reported to the FDA’s MedWatch Program by

fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville,

MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

The affected product lot numbers for the recalled products can be found on the

side of the bottle label.

McNeil Consumer Healthcare Division of McNeil-PPC, Inc. markets a broad range of

well-known and trusted over-the-counter (OTC) products.

CLICK HERE FOR RECALL INFORMATION ON CERTAIN PRODUCT LOTS OF TYLENOL® Products