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Archived – TYLENOL Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP
- Starting date:
- December 31, 2009
- Posting date:
- December 31, 2009
- Type of communication:
- Foreign Product Alert (FPA)
- Subcategory:
- Natural health products
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information, Contamination
- Audience:
- General Public
- Identification number:
- RA-12000998
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.
Source of alert
The U.S. Food and Drug Administration
Product name
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.
What you should do
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.
Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.
Background
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.
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.
Report a health or safety concern
- Call toll-free at 1-866-234-2345.
-
Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
Media enquiries
Health Canada
613-957-2983
Public enquiries
613-957-2991
1-866-225-0709
Images
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