Voluntary Type 1 Recall of Depakene^® (valproic acid) 500-mg Enteric-Coated Capsules in Canada

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Contact: Drug Compliance Verification & Investigation Unit (DCVIU)

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
 
This is duplicated text of a letter from Abbott Laboratories, Limited.
Contact the company for a copy of any references, attachments or enclosures.

Public Communication
Health Canada Endorsed Important Safety Information on the Recall of Depakene (valproic acid) 500-mg Enteric-Coated Capsules

May 14, 2007

Subject: Urgent Product Recall Voluntary Type I Recall of Depakene^® (valproic acid) 500-mg Enteric-Coated Capsules in Canada

Dear Patient:

Abbott Laboratories, Limited (Abbott) and Health Canada are advising the public of a voluntary recall of Depakene^® (valproic acid) 500-mg enteric-coated capsules. Depakene^® (valproic acid) is a prescription medication used to treat epilepsy. Routine product testing indicated that the product's shelf-life is not as long as marked on the packaging. As a result, a lesser amount of active ingredient may be released. This may result in inadequate seizure control, potentially putting patients at risk for a greater number of seizures.

In addition, due to changes in manufacturing availability, Depakene^® (valproic acid) 500-mg enteric-coated capsules is permanently discontinued as of May 11, 2007 and will no longer be available in Canada.

No other Depakene^® formulation or Abbott product is affected by this action.

Patients must return Depakene^® (valproic acid) 500-mg enteric-coated capsules to their pharmacists.

As with any drug product, in order to avoid contaminating ground or municipal water systems, the product should not be flushed down the toilet or sink.

Abbott has sent a letter to Canadian health care professionals notifying them of this important voluntary recall. You may view this letter on the Abbott website at  http://www.abbott.ca. The Public Communication will be also posted on Health Canada website.

Abbott reiterates its commitment to the health and safety of patients and the delivery of quality products.

Should you have any questions or require additional information regarding the recall of Depakene^® (valproic acid) 500-mg enteric-coated capsules, please contact your health care provider.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reactions in patients receiving Depakene^® (valproic acid) 500-mg enteric-coated capsules should be reported to Abbott or Health Canada at the following addresses: