2006-94
September 27, 2006
For immediate release
OTTAWA - Health Canada is advising consumers not to use AstraZeneca Xylocaine® 2% Jelly Single Use Plastic Syringes (10 ml) due to the risk of a small plastic fragment remaining in the applicator tip of the syringe after the protective seal is broken. The plastic fragment may break away and block the syringe or be dispersed with the jelly.
Xylocaine 2% Jelly is used as a surface anesthetic and lubricator for tests or intubation of the urinary tract, respiratory tract, anal canal and stomach. It is also used for the treatment of pain caused by inflammation of the urinary tract and bladder. Although this product is most commonly administered by health care professionals, there are some indications for which it can be self-administered by the patient.
The affected product, manufactured by AstraZeneca in Sweden and distributed by AstraZeneca Canada Inc., is sold in 10-ml single-use clear syringes. AstraZeneca voluntarily initiated a recall on September 22, 2006 and Health Canada continues to monitor its effectiveness.
Plastic fragments introduced in the body could result in pain, discharge or blood at urination, inflammation of the urinary tract, urinary bladder stones, nasal discharge, intense coughing or recurrent respiratory infections. There is also a very small risk of perforation of the intestine. Children may be particularly vulnerable to the pain and symptoms caused by the accidental insertion of plastic fragments in sensitive body cavities.
Consumers are advised to stop using AstraZeneca Xylocaine 2% Jelly Single Use Plastic Syringes and return the product to the point of purchase. Consumers concerned after using this product are advised to consult a health care professional.
No other Xylocaine product is affected by this recall.
Consumers requiring more information can contact Health Canada's public inquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse reaction to this or any other health product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
CADRMP
Marketed Health Products Directorate
Tunney's Pasture, AL 0701C
email: cadrmp@hc-sc.gc.ca
The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online, is located on the MedEffect portal of the Health Canada Web site.
Health Canada issues Public Advisories to inform the public of possible serious health hazards and enable Canadians to make informed decisions concerning the continued use of a consumer or marketed health product.
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Media Inquiries:
Carole Saindon
Health Canada
(613) 957-1588
Public Inquiries:
(613) 957-2991
1-866 225-0709
