Compliments Extra Strength Acetaminophen Gelcaps Labelling Error: May Cause Serious Harm to Children

Starting date:
April 18, 2012
Posting date:
April 18, 2012
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product Safety, Labelling and Packaging
Audience:
General Public
Identification number:
RA-110005604

Health Canada is advising Canadians that Vita Health Products is conducting a voluntary recall of five lots (see chart below) of Compliments Extra Strength Acetaminophen Gelcaps 500 mg (bottles of 120 gelcaps).

The products are being recalled because its packaging suggests the product is child resistant but the product has been packaged with a non-child-resistant cap. As such, there is no child safety mechanism, which presents a risk to children who are able to open the bottle and ingest the product. The risk of ingestion by children less than 12 years of age can result in acetaminophen overdose and serious health consequences including liver damage. Early signs of overdose include nausea, vomiting lethargy and sweating. Liver damage may result in liver failure or death.

Vita Health Products is requesting that retailers immediately stop sale of this product and return their products to the company. To date, Vita Health Products has confirmed the products were distributed to Sobeys & IGA retail locations. It’s also important to note that they may also be found at other retail locations across Canada.

Health Canada is monitoring the recall by Vita Health Products. Should new information be identified, Health Canada will continue to provide an update to Canadians.

Health Canada reminds Canadians who have concerns about these products to consult with their health care practitioner. Canadians wishing more information on this recall may contact Vita Health at 1-800-665-8820, Monday-Friday 9 a.m.-5:30 p.m. EST for further instruction. Media wishing more information on this recall may contact Brian Ellis 1-804-675-8140.

Compliments Extra Strength Acetaminophen Gelcaps Labelling Error
Finished Good UPC Description Lot Number Date of Manufacture Date of Expiry
055742518559 Compliments Extra Strength Acetaminophen Gelcaps 500 mg 120 count 1B01829H9 Oct 2010 Oct 2012
1B01929H9 Oct 2010 Oct 2012
1E1742EGG Feb 2011 Feb 2013
1I10102GMB June 2011 June 2013
1K1672KME Sept 2011 Sept 2013

 

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