The following is to update Canadians on the recall of contaminated lots of heparin products from B. Braun Medical Inc., and the ongoing testing of the heparin supply in Canada.The contaminant found in the B. Braun products, oversulfated chondroitin sulfate, and has also been found in heparin products in other countries, including the United States.
Health Canada has been in contact with all distributors and manufacturers of heparin products in Canada since March 11, 2008, when the department asked them to confirm that all lots currently sold in Canada have been tested and are free of the identified contaminants. Company results are due by this week.
Heparin primarily acts as a blood thinner, preventing the formation of clots, and is used after surgery and in dialysis. Heparin is used when medically necessary after careful weighing of the risks and benefits for each patient. Patients should be monitored during and immediately following heparin administration for signs of allergy or anaphylactic reaction.
The presence of a contaminant in the active pharmaceutical ingredients of certain lots of B. Braun heparin products was first identified by Health Canada and communicated to Canadians on March 20, 2008.
This contaminant has been found in the following specific products and lots, which are being recalled:
Lot number: J7D580, J6N438, J6J492, J5P643
Description: Heparin Sodium 20,000 units in 5% Dextrose Injection, 500 mL
Drug Identification Number (DIN): 02209713
Lot number: J7E577 J6L669 J5S669
Description: Heparin Sodium 25,000 units in 5% Dextrose Injection, 500 mL
Drug Identification Number (DIN): 01935941
Lot number: J7E420, J6K645, J6H487
Description: Heparin Sodium 25,000 units in 5% Dextrose Injection, 250 mL
Drug Identification Number (DIN): 02209721
Lot number: J7D485, J7C477, J6L453, J6K639, J6K567, J6J613, J6H716, J6H630, J6B493, J6A679, J6A422, J5N567
Description: Heparin Sodium 1,000 units in 0.9% Sodium Chloride Injection USP, 500 mL
Drug Identification Number (DIN): 01935933
Consumers requiring more information about this Information Update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
see: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2008/2008_52_e.html
