CanadaHow to identify it
Brand name: Fludarabine Phosphate Injection, USP 50mg/2mL (25 mg/mL); Dosage form and route of administration: Solution Intravenous; Country of authorization and identifying code: US NDC: 59923-604-02; Manufacturer: Areva Pharmaceuticals, Inc.; Importer in Canada: Septa Pharmaceuticals Inc.
The hazard
There is a shortage of Fludarabine Phosphate Injection in Canada. Given the medical necessity of Fludarabine Phosphate Injection and the need to maintain continuity of supply in Canada, Health Canada has authorized the exceptional, temporary importation and sale of US-authorized Fludarabine Phosphate Injection, USP with English-only labels, by Septa Pharmaceuticals Inc.
Healthcare professionals should be aware of important differences between the US-authorized and Canadian-authorized products (see Information for healthcare professionals section).
What to do
See Key Messages below
Where it was sold
National
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)