TYLENOL® Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP

Foreign Product Alert
2009-213
December 31, 2009
For immediate release

Health Canada is advising consumers not to use the following products specified below due to concerns about possible side-effects. More info

Source of Alert

The U.S. Food and Drug Administration

Product Names

TYLENOL® Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP

Manufacturer / Place of Origin

The manufacturer McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is located in the U.S.A.

Product Description

TYLENOL® Arthritis Pain Caplets is an acetaminophen product used to provide arthritis pain relief.

Reason for Warning

The U.S. Food and Drug Administration informed consumers to stop using TYLENOL® Arthritis Pain Caplet 100 count bottles purchased in the United States. The manufacturer has recalled this product after consumer reports of an unusual mouldy, musty, or mildew-like odour that was associated with nausea, stomach pain, vomiting and diarrhea.

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.

Possible Side-Effects

The health effects of this compound have not been well studied, and to date all of the observed events (e.g. nausea, stomach pain, diarrhea, etc.) reported to the manufacturer were temporary and non-serious.

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Media Enquiries:
Health Canada
(613) 957-2983

For more details on these Foreign Product Alerts, please visit the Health Canada Web site.

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These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the products listed above in the Canadian marketplace.

For more information about the information contained in this advisory, please contact Health Canada's public inquiries line at (613) 957-2991 or toll-free at 1-866-225-0709.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.