Other safety alerts
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| Canada: Health Canada Endorsed Important Safety Information on Potassium Phosphates Injection USP, Potassium Phosphate Monobasic Injection and Sodium Phosphates Injection USP manufacturerd by Sandoz Canada Inc. |
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Sandoz Canada Inc., in consultation with Health Canada announced that particulate matter was observed in some vials of one lot of Potassium Phosphates Injection USP 10 ml vials that has not been released on to the Canadian market. Due to the potential for particulate matter in other sterile injectable sodium and potassium phosphate products, healthcare professionals are advised to use an in-line filter when administering any of these phosphate products. These products are distributed in Canada by Baxter.
Potassium Phosphates Injection USP is indicated as a potassium supplement, Potassium Phosphate Monobasic Injection as an electrolyte supplement and Sodium Phosphates Injection USP as an electrolyte replenisher. These products are approved for intravenous administration after dilution.
Inadvertent injection of particulate matter could result in local inflammation, phlebitis, allergic response and/or embolization in the body. Since the release of the potentially affected phosphate injectable products, no adverse event reports related to this issue were received at Sandoz Canada Inc. As a precautionary measure, all parenteral drug products should be inspected visually for the presence of particulate matter.
Please refer to the following website in Health Canada for details:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../36839a-eng.php
In Hong Kong, the above products are not registered pharmaceutical products. However, only one product namely Multi-12 for IV INF. (HK-53536) is manufactured by Sandoz Canada Inc. and registered in Hong Kong. As confirmed by the registration holder, Multi-12 for IV INF. (HK-53536) is not affected by this incident.
Ends/ Friday, November 22, 2013
Issued at HKT 17:30 |
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