Warning
1998-31
May 12, 1998
Warning regarding use of Epipen and Epipen Jr. auto injectors
OTTAWA - To ensure that all consumers of EpiPen and EpiPen Jr. auto injectors have been reached, Health Canada is advising consumers who use EpiPen and EpiPen Jr. auto injectors to immediately return these products to the pharmacy for free replacement. These products are used in the event of an onset of severe, even life-threatening allergies.
Four lots of the product are being recalled: two lots of EpiPen, lot numbers 7C6214 and 7C6279, and two lots of EpiPen Jr. lot numbers 7C5376 and 7C5238. These four lots are being recalled because some of the auto injectors may not provide enough quantities of epinephrine to effectively treat acute allergic reaction (anaphylaxis) due to a defect in the auto injector's design. This recall pertains only to the four aforementioned lot numbers. EpiPen and EpiPen Jr. are sponsored by Dey Laboratories, Napa, California in the United States and are distributed in Canada by Allerex Laboratory Ltd. in Kanata, Ontario.
Should an Allerex replacement product not be readily available, patients should contact their physicians or pharmacists immediately for advice regarding alternatives. If an emergency occurs prior to the product being replaced, patients are advised to use the product.
The Canadian distributor has voluntarily stopped sale of the defective model of EpiPen and EpiPen Jr. auto injector. There has been no report of death or injuries in Canada.
Health Canada is issuing this warning to advise consumers, the Canadian Medical Association, the Canadian Pharmacists Association, the Allergy Information Association, the Anaphylaxis Network of Canada, the Canadian School Board Association, the Canadian Society of Allergy and Clinical Immunology and the provincial Ministries of Health of the recall of this product.
Information:
Tony Halisky
Health Canada
Pager 613-791-3105
Health Canada Regional Offices:
Atlantic region 902-426-7598
Quebec region 514-646-1353
Ontario region 416-973-1475
Manitoba and Saskatchewan 204-983-5451
Alberta, British Columbia, Northwest Territories and Yukon 604-666-3704
Allerex Laboratory Ltd
1-800-897-4177
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