CanadaUS-authorized Vasopressin Injection, USP, 20 units/mL for IV infusion — preservative-free 1 mL single-dose vials (tray of 25) with English-only labels, NDC 63323-930-00/63323-930-01, manufactured by Fresenius Kabi USA and imported by Fresenius Kabi Canada — has been permitted for temporary importation into Canada. Health Canada authorized this exceptional importation because of a shortage of the Canadian-authorized Vasopressin Injection, USP, 20 units/mL for intramuscular or subcutaneous administration; the US product is similar but not identical.
How to identify it
Product Brand Name: Vasopressin Injection, USP; Dosage Form, Strength, and Packaging Format: Sterile, aqueous solution for IV infusion (must be diluted prior to use); 20 units/mL; 1 mL single- dose vial. Preservative-free.; Country of Authorization and Identifying Code: United States of America Product Code: (930101) Each vial: NDC 63323-930-00 1 mL Single- Dose Vial Unit of Sale: NDC 63323- 930-01 A tray of 25 Single-Dose Vials; Manufacturer: Fresenius Kabi USA, LLC; Importer in Canada: Fresenius Kabi Canada Ltd.
The hazard
There is a shortage of Vasopressin Injection, USP, 20 units/mL (for intramuscular [IM] or subcutaneous [SC] administration) in Canada. This shortage presents serious risks to patients who may require vasopressin therapy in critical care settings, based on the clinical judgment of qualified healthcare professionals. Given the medical need, Health Canada has permitted the exceptional, temporary importation and sale of a similar but not identical product, US-authorized Vasopressin, USP, 20 units/mL (for intravenous [IV] infusion), with English-only labels by Fresenius Kabi USA, LLC.
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)