Health Canada Authorizes Import of US Vasopressin Injection Amid Critical Shortage

What Happened

Health Canada has announced the exceptional, temporary importation and sale of US-authorized Vasopressin Injection, USP (20 units/mL) to address a current shortage of the Canadian-authorized version (DIN 02139502). The US-authorized product, manufactured by Fresenius Kabi USA, LLC, is similar but not identical to the Canadian product. Specifically, the US version is intended for intravenous (IV) infusion, whereas the Canadian version is authorized for intramuscular (IM) or subcutaneous (SC) administration.

Which Products Are Affected

The following product is being imported from the United States to Canada:

• Product Name: Vasopressin Injection, USP
• Strength: 20 units/mL
• Format: 1 mL single-dose vial (Preservative-free)
• Manufacturer: Fresenius Kabi USA, LLC
• Importer: Fresenius Kabi Canada Ltd.
• Identifying Codes:
  • Vial NDC: 63323-930-00
  • Unit of Sale NDC: 63323-930-01 (Tray of 25 vials)
  • Product Code: 930101
• Labeling: The imported product features English-only labels.

What You Should Do

Healthcare professionals, including emergency and critical care physicians, anesthesiologists, and pharmacists, are advised to:

• Verify Administration Route: Be aware that the US-authorized product is intended exclusively for IV infusion after dilution. It is not labeled for IM or SC use, and the safety of those administration routes has not been established for this specific formulation.
• Check for Differences: Note that the US product differs from the Canadian version in indication, packaging, formulation, dilution requirements, storage conditions, and in-use periods.
• Consult Documentation: Healthcare providers should consult the US Prescribing Information (USPI) for complete safety and administration details.

Why This Matters

The shortage of Canadian-authorized vasopressin presents serious risks to patients requiring therapy in critical care settings. While the imported US product provides a necessary alternative, the significant differences in administration routes and preparation requirements necessitate heightened awareness to prevent medical errors.

Source

Health Canada