Safeway Extra Strength Ibuprofen: Labelling Error Could Lead to Serious Harm to Children

Starting date:
June 6, 2013
Posting date:
June 6, 2013
Type of communication:
Information Update
Subcategory:
Drugs, Affects children, pregnant or breast feeding women
Source of recall:
Health Canada
Issue:
Labelling and Packaging
Audience:
General Public
Identification number:
RA-33929

Issue

Health Canada is advising Canadians that Vita Health Products Inc. is voluntarily recalling all lots of Safeway Extra Strength Ibuprofen Liquid Capsules (400 mg capsules, 50 in a bottle). The recall is due to a labeling error that incorrectly states the product is packaged with a child-resistant bottle and cap.

As there is no child safety mechanism, this presents a risk to children who could open the bottle and ingest the product. The risk of ingestion by children can result in ibuprofen overdose and serious health consequences including, seizures, kidney failure, heart problems and coma. Early signs of overdose include nausea, vomiting, lethargy and abdominal pain.

Vita Health Products Inc. is requesting that retailers immediately stop sale of this product and return their products to the company. Consumers who have any of these products in their possession should return the product to the place of purchase.

Vita Health Products Inc. has informed Health Canada that as of June 6, 2013, there had been no adverse events reported concerning this product. As well, Health Canada has not received any adverse reactions reports.

Health Canada is monitoring the recall by Vita Health Products Inc. 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. Consumers may call the company at 1-(800)-665-8820, Monday-Friday 9:00 am – 5:30 pm EST for further instruction. 

The information contained in this chart will help consumers identify if they are in possession of the affected product.
UPC Description Lot number Manufacture Date Expiry Date
058200764567 Safeway Extra Strength
Ibuprofen Liquid Capsules
400 mg 50 count
1I0802CCY 09/2011 06/2013
1I0812CCY 09/2011 06/2013
1I0842KK2 09/2011 06/2013
2A1432NWR 01/2012 12/2013
2A1442NWR 01/2012 12/2013
2C0702S11 03/2012 12/2013
2F0982V0U 06/2012 02/2014
3B2062XRR 02/2013 12/2014
3D2692Z58 04/2013 12/2014

 

Report health or safety concerns

  • 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.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

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1-866-225-0709