Updated Information Regarding Recalled Infant and Children Motrin and Tylenol Products

Information Update
2010-67
May 4, 2010
For immediate release

OTTAWA - Following the recent recall of Children and Infant's Motrin and Tylenol products by McNeil Consumer Healthcare, Health Canada is updating Canadians on our completed risk assessment of the products. The department's assessment concurs with statements issued by the United States Food and Drug Administration and McNeil Consumer Healthcare that the probability of a serious adverse reaction associated with the affected recalled products is very low. However, quality issues have been identified by the United States Food and Drug Administration concerning the manufacturing of the affected recalled products.

McNeil Consumer Healthcare is advising Canadians who have purchased these recalled products to discontinue use. Health Canada reminds Canadians who have concerns about these products to consult with their health care practitioners or contact the company at 1-888-222-6036 or visit: http://www.mcneilcanada.com.

Health Canada is continuing to work with the United States Food and Drug Administration in reviewing McNeil Consumer Healthcare's corrective actions taken at the U.S. plant where these products were manufactured. Should evidence submitted not demonstrate compliance with Canadian regulations, Health Canada will take appropriate action.

Health Canada will also continue monitoring the safety of all health products on the Canadian market, including those manufactured at McNeil Consumer Healthcare plants and will inform Canadians if new safety information arises. Canadians can be confident that should any risks to health be identified, Health Canada will take immediate and appropriate action to help protect the health and safety of Canadians.

Product Recall Information

Description	DIN
Infant's MOTRIN* Suspension Drops Dye-Free 30ml	02238626
Infant's MOTRIN* Suspension Drops Dye-Free 15ml	02238626
Children's MOTRIN* Suspension Dye-Free 120ml	02242365
Children's MOTRIN* Suspension 120ml	02242365
Children's MOTRIN* Suspension Grape 120ml	02242365
Children's MOTRIN* Suspension Grape 30ml	02242365
Children's MOTRIN* Suspension Bubblegum 120ml	02242365
Children's MOTRIN* Suspension Tropical Punch 120ml	02242365
Infant's MOTRIN* Suspension for Fever due to Colds/Flu 30ml	02238626
Children's MOTRIN* Suspension for Fever due to Colds/Flu 120ml	02242365
Children's TYLENOL* Cough & Runny Nose Suspension 100ml	02292122

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at the MedEffect™ Canada Web site
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to: Canada Vigilance Program
    Health Canada
    AL 0701D
    Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada Web site. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this website.

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