OTTAWA, ONTARIO - Health Canada is advising consumers of a recall of Desferrioxamine Mesilate for Injection (500 mg and 2g format) by Hospira Healthcare Corporation. Certain lots of this product are being recalled because of the potential for very small particles to form after preparation for intravenous administration.
Health Canada is working with the company on the recall of the affected Canadian products from the market. The following specific lots are being recalled:
Lot number: U072231AA in 500mg format
Lot number: U102237AA in 2g format
The lot number is found on the label of the carton and on the vial of the 2 formats of Desferrioxamine Mesilate.
Please note that Hospira Healthcare Corporation has acquired this product from Mayne Pharma (Canada) Inc, and therefore the product will bear the name Mayne Pharma Canada Inc. on the label and carton.
The problem with these lots is related to the drug substance which may produce some cloudiness after preparation. The cloudiness is a result of very small particles that form when preparing the solution. These products are administered by intravenous injection and therefore these particles may induce blockage of small blood vessels. It is recommended that if the prepared solution becomes cloudy, it should not be administered.
Desferrioxamine Mesilate is prescribed for the treatment of acute/chronic iron intoxication and chronic aluminum overload in dialysis patients with end-stage renal failure.
There may be cases in which this product is present in a patient's home. These patients are advised to check for the DIN and lot number on the product packaging or consult with their pharmacist to determine whether or not they have drug product from the affected lots. Any product from an affected lot should be returned to the pharmacy for replacement. Patients should not stop the use of Desferrioxamine Mesilate without consulting a health care practitioner.
Patients should consult their physician or pharmacist if they are concerned they have been given products from these lots or if they experience an adverse reaction. There are currently no adverse reaction reports related to this recall that have been reported to Health Canada.
Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) at the MedEffect(TM) Canada Web site
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php)and either:
- Fax toll-free to 1-866-678-6789
- Mail to: Canada Vigilance Program
Health Canada
AL 0701C
Ottawa, ON K1A 0K9
To have postage pre-paid, download the postage paid label (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/post_paid-affranchi-eng.php) from the MedEffect(TM) Canada Web site. The Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) and the adverse reaction reporting guidelines may also be obtained via this Web site.
Health Canada is working with the company on the recall of the affected Canadian products from the market. The following specific lots are being recalled:
Lot number: U072231AA in 500mg format
Lot number: U102237AA in 2g format
The lot number is found on the label of the carton and on the vial of the 2 formats of Desferrioxamine Mesilate.
Please note that Hospira Healthcare Corporation has acquired this product from Mayne Pharma (Canada) Inc, and therefore the product will bear the name Mayne Pharma Canada Inc. on the label and carton.
The problem with these lots is related to the drug substance which may produce some cloudiness after preparation. The cloudiness is a result of very small particles that form when preparing the solution. These products are administered by intravenous injection and therefore these particles may induce blockage of small blood vessels. It is recommended that if the prepared solution becomes cloudy, it should not be administered.
Desferrioxamine Mesilate is prescribed for the treatment of acute/chronic iron intoxication and chronic aluminum overload in dialysis patients with end-stage renal failure.
There may be cases in which this product is present in a patient's home. These patients are advised to check for the DIN and lot number on the product packaging or consult with their pharmacist to determine whether or not they have drug product from the affected lots. Any product from an affected lot should be returned to the pharmacy for replacement. Patients should not stop the use of Desferrioxamine Mesilate without consulting a health care practitioner.
Patients should consult their physician or pharmacist if they are concerned they have been given products from these lots or if they experience an adverse reaction. There are currently no adverse reaction reports related to this recall that have been reported to Health Canada.
Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) at the MedEffect(TM) Canada Web site
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php)and either:
- Fax toll-free to 1-866-678-6789
- Mail to: Canada Vigilance Program
Health Canada
AL 0701C
Ottawa, ON K1A 0K9
To have postage pre-paid, download the postage paid label (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/post_paid-affranchi-eng.php) from the MedEffect(TM) Canada Web site. The Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) and the adverse reaction reporting guidelines may also be obtained via this Web site.
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Contacts:
Media Inquiries:
Health Canada
613-957-2983
Public Inquiries:
613-957-2991
1-866-225-0709
© MarketWire 2009
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