Health Canada



Health Canada

June 21, 2013 20:30 ET

ACET-650 Suppositories: Two Lots Recalled Due to Mislabelling and Potential Overdose Risk

OTTAWA, ONTARIO--(Marketwired - June 21, 2013) -

The issue:

In consultation with Health Canada, Pendopharm, a division of Pharmascience Inc., is voluntarily recalling two lots of the ACET-650 acetaminophen suppository (DIN 02230437) due to dosage mislabelling on the blister packs inside the box. In the affected lots, some of the suppositories containing 650 mg may be labelled as 325 mg on the blister packs. The external box indicates the correct dose, 650 mg.

Due to the error in the labelling, there is a possibility of overdosing, which could potentially lead to liver failure or death. If 650 mg of acetaminophen is taken instead of 325 mg every 4-6 hours, this would exceed the maximum daily dose for children and adults.

ACET-650 is an over-the-counter (non-prescription) acetaminophen suppository indicated for relief of mild to moderate pain, and to reduce fever.

Who is affected:

Canadians who have purchased ACET-650 (DIN 02230437) (see list of affected product below).

As of June 21, 2013, Health Canada has not received any adverse drug reaction report.

What consumers should do*

• Contact your healthcare professional with any questions or concerns regarding the use of this product.

• Report any adverse reaction potentially related to these products to Health Canada.

What Health Canada is doing:

Pendopharm, a division of Pharmascience Inc., is voluntarily recalling the affected product from Canadian retailers. Health Canada is monitoring the recall.

Background:

Taking more than the maximum daily dose may cause severe or possibly fatal liver damage. Early signs of overdose of acetaminophen include nausea, vomiting, lethargy and sweating. Liver damage may result in liver failure or death. Abdominal pain may be the first sign of liver damage and may not be apparent for 24 to 48 hours.

Products recalled/affected:
This recall affects lots L929 and L930 of ACET-650 SUPPO 12
(DIN 02230437)

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

More information is also available from Pendopharm, a division of Pharmascience Inc., by calling 1-888-550-6060.

How to report problems with consumer products (or) How to report side effects to health products to Health Canada:

• Call toll-free at 1-866-234-2345

• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

Également disponible en français

A photo of the product is available at the following address: http://media3.marketwire.com/docs/acet650_eng.pdf

Contact Information

  • Media Inquiries:
    Health Canada
    613-957-2983

    Public Inquiries:
    613-957-2991
    1-866-225-0709