Novartis Recall of Excedrin Products Extends to Canada

Starting date:

January 13, 2012

Posting date:

January 13, 2012

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Labelling and Packaging, Product Safety

Audience:

General Public

Identification number:

RA-110005244

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Health Canada is advising Canadians that Novartis Consumer Health Inc’s U.S. recall is now being extended to Canada. According to Novartis Consumer Health Canada Inc, the Canadian recall includes all lots (expiration dates of December 20, 2014 and earlier) for over-the-counter products, Excedrin Extra Strength Caplets and Excedrin Tension Headache Caplets.

According to the FDA, Novartis Consumer Health Over-The-Counter Products: Recall - Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps and inconsistent bottle packaging clearance practices, which could result in the bottles containing foreign tablets, caplets, or capsules. The U.S. FDA has informed consumers that mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient.

Canadians can be confident that Health Canada is monitoring the voluntary recall by Novartis Consumer Health Canada Inc. Should additional information be identified, Health Canada will take appropriate action and inform Canadians.

Health Canada reminds Canadians who have concerns about these products to consult with their health care practitioner. For information concerning the recall or how to return the affected product, consumers should directly contact Novartis Consumer Health Canada Inc’s consumer relationship centre at the following number 1-888-788-8181.

Report health or safety concerns

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:

Fax: 1-866-678-6789
E-mail: CanadaVigilance@hc-sc.gc.ca
Internet: MedEffect Canada
Mail: Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701C
K1A 0K9

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

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