Drug maker recalls Tylenol arthritis product

The maker of Tylenol, McNeil Consumer Healthcare, has issued a nationwide recall of all lots of its Tylenol Arthritis Pain 100 count bottles that have a red “EZ-OPEN CAP”.

The recall was issued after consumers reported an “unusual moldy, musty or mildew-lik odor that was associated with nausea, stomach pain, vomiting and diarrhea,” the company said in a press release announcing the recall.

The uncharacteristic smell is caused by the presence of trace amounts of a chemical called  2,4,6-tribromoanisole.  The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious.

Consumers should stop using the product and contact the company for instructions on how to obtain a refund or replacement, the company said.

“Consumers who have medical concerns or questions should contact their healthcare provider,” the company said.

To learn more:

• For these instructions or information regarding how to return or dispose of the product, consumers should call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) or log on to the internet at www.tylenol.com.
• Read the full text of the company’s recall notices (below), which includes the lot numbers of the products being recalled.

TEXT of

Mcneil Consumer Healthcare Announces A Voluntary Nationwide Recall Of All Lots Of Tylenol® Arthritis Pain 100 Count With Ez-Open Cap

FOR IMMEDIATE RELEASE – December 18, 2009 – Fort Washington, PA – In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is expanding its voluntary recall to include all available product lots of TYLENOL® Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP (Full list of lot numbers provided below). In November 2009, 5 lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea.  The recall is being expanded, as a precaution, to include all TYLENOL® Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP.

The uncharacteristic smell is caused by the presence of trace amounts of a chemical called  2,4,6-tribromoanisole.  The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious.

Consumers who purchased TYLENOL® Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement.   For these instructions or information regarding how to return or dispose of the product, consumers should call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) or log on to the internet atwww.tylenol.com.  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 TYLENOL® Arthritis Pain Caplet 100 count product lot numbers can be found on the side of the bottle label. See the full list of affected product lot numbers below:

Recalled Product- Full List (LINK: http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tar_recall.inc

Tags: Product Recall, Tylenol

Category: Bones, Joints & Muscles, Drugs & Medicines, Product Recall