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Information update

Important Information for Multiple Sclerosis Patients: COPAXONE® Co-packaged with Recalled Alcohol Prep Pads

Starting date:: January 12, 2011
Posting date:: January 12, 2011
Type of communication:: Information Update
Subcategory:: Drugs
Source of recall:: Health Canada
Identification number:: RA-15203

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OTTAWA - Following our communication regarding the Shandex Sales Group's voluntary recall of alcohol swabs manufactured by Triad from the Canadian market, Health Canada is informing Canadians that the drug, COPAXONE®, used in the treatment of Multiple Sclerosis, has been co-packaged in a kit produced by Teva with recalled alcohol prep pads manufactured by Triad.

Alcohol prep pads closely resemble alcohol swabs and are used for the same purpose: to cleanse or disinfect a particular area of the body.

Teva is advising patients to continue their daily injection routine using the Copaxone prefilled syringe. Instead of using the Triad brand alcohol prep pads that were packaged with COPAXONE®, Teva is advising patients to use alternative alcohol pads, which are available for purchase at their local pharmacies, or to use bottled isopropyl alcohol (70%) with a cotton ball.

Health Canada has also been informed by Teva that they are working with patients, health care professionals, pharmacies, wholesalers and the MS Society of Canada to communicate this important information. To date, Health Canada has not received any reports of adverse reactions related to the use of Triad alcohol swabs or prep pads.

Health Canada would also like to remind Canadians who have concerns about these products to consult with their health care practitioner or directly contact the company at 1-800-283-0034. Should any new information be identified, Health Canada will continue to update Canadians.

To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

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Fax: 1-866-678-6789
Internet: www.healthcanada.gc.ca/medeffect
Mail: Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701E
K1A 0K9