OTTAWA, ONTARIO -- (Marketwire) -- 03/22/12 -- The issue:
Following our March 21, 2012, Notice to Hospitals and Notice to Healthcare Professionals, Health Canada is advising Canadians that Sandoz Canada Inc. will be voluntarily recalling a portion of one lot of 2mg/mL (1mL) Morphine Sulfate Injection (Lot CC2824 exp. 2014-12) from the Canadian market. The recall applies to all products that has been distributed to healthcare providers.
The recall is in light of a report from a Toronto hospital that found one box labelled as morphine ampoules (vials) which incorrectly contained ampoules of isoproterenol.
Sandoz has remaining inventory of the affected Lot which has not been distributed. In light of current supply constraints and to minimize the impact on Canadians, Sandoz Canada is currently inspecting its inventory of morphine packages from the affected lot to confirm that all of the morphine packages contain the correct product. Once Sandoz Canada has verified that all of the packages contain the correct product, the inventory will be clearly marked to indicate it has been inspected and can be released on the market. Products that are currently in distribution and that are being recalled will not be re-released.
Who is affected:
Healthcare professionals, hospitals, clinics and other health institutions that may have supply of the recalled product in stock.
What healthcare professionals should do:
-- For information concerning the recall or how to return the affected
product, contact Sandoz Canada directly, toll-free, at 1-877-650-0751
-- Submit complaints regarding the safety, efficacy or quality of health
products to Health Canada's Inspectorate, toll-free, at 1-800-267-9675.
What Health Canada is doing:
On March 21, Health Canada issued a Notice to Hospitals and Notice to Healthcare Professionals, advising that product from the affected lots should be quarantined until further notice.
Health Canada is monitoring the voluntary recall and will continue to work closely with Sandoz Canada.
The Department continues to provide updated information to provinces and territories, and will communicate new information to Canadians, as appropriate.
Health Canada has not received any reports of patient harm involving this packaging error.
Background:
Inadvertent use of Isoproterenol Hydrochloride Injection USP instead of Morphine Sulfate Injection USP can result in serious health effects. Patients will not receive the intended morphine therapy. As well, Isoproterenol Hydrochloride is a powerful adrenergic agent. It is associated with a risk of tachycardia and arrhythmia, which may be life threatening. Other side effects may include headache, tremor and sweating.
The recalled product is as follows: Morphine Sulfate Injection USP 2mg/mL (1mL) Lot CC2824 exp. 2014-12 DIN 02242484 UPC 057513056420
An image of the product is available at the following address: http://media3.marketwire.com/docs/Morphine_Sulfate.pdf
For more information:
Sandoz Canada- Media Enquiries:
Telephone: 450-641-4903, ext. 2518 Toll-free: 1-800-343-8839, ext. 2518 E-mail: communications.canada@sandoz.com
Health Canada:
Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.
Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.
How to report side effects to health products:
To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:
-- Fax: 1-866-678-6789
-- E-mail: CanadaVigilance@hc-sc.gc.ca
-- Internet: www.healthcanada.gc.ca/medeffect
-- Mail: Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701C
K1A 0K9
Stay connected with Health Canada and receive the latest advisories and product recalls using these social media tools: http://www.hc-sc.gc.ca/home-accueil/sm-ms/index-eng.php
Egalement disponible en francais
Contacts:
Media Inquiries:
Health Canada
613-957-2983
Public Inquiries:
613-957-2991
1-866-225-0709
