Advisory
2004-33
June 18, 2004
For immediate release
Health Canada advises health professionals and consumers about penicillin allergy test recall
OTTAWA - Health Canada advises health professionals and consumers of a potential risk related
to Pre-Pen, a product used to test an individual's allergy to penicillin. Pre-Pen is distributed
in Canada by Omega Laboratories Ltd.
Recent information provided to Health Canada shows that lot number 91121 of this product,
which has been available since November 2003, is subpotent. This means that test results may
be inaccurate and that some people might be falsely diagnosed as not having a penicillin allergy.
As a precaution, Health Canada is advising patients tested for penicillin allergy since November 2003 to
avoid the use of penicillin products and consult their physician for further advice on testing for
allergies.
Health Canada is working with the distributor to inform physicians, hospital administrators and
pharmacists of this potential risk and to recall the product.
The identification, characterization, and management of marketed health product-related adverse
reactions are dependent on the active participation of health care professionals in adverse reaction
reporting programmes. Any occurrences of serious and/or unexpected adverse reactions in patients
using Omega Laboratories' Pre-Pen should be reported to Health Canada at the address below.
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Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or
Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
For other inquiries: please refer to contact information.
The AR Reporting
Form and the AR
Guidelines can be found on the Health Canada web site or in The Canadian Compendium
of Pharmaceuticals and Specialties.
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Media Inquiries:
Paige Raymond Kovach
Health Canada
(613) 948-4629
Public Inquiries:
(613) 957-2991
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