Fludeoxyglucose (18F) Injection (2020-03-16)

Starting date:

March 16, 2020

Type of communication:

Drug Recall

Subcategory:

Drugs

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

Healthcare Professionals, Hospitals

Identification number:

RA-72795

Last updated: 2020-04-16

Summary

• Product:
  Fludeoxyglucose (18F) Injection

• 
  Reason
• 
  Depth of distribution
• 
  Affected products

Reason

Low final product activity in vial.  The radiopharmaceutical product (single vial) was manufactured and delivered within minutes to the sole client - who upon receipt measured the activity and found that there was approximately 20% less activity than declared.  The underdosage was traced to an internal leak within the manufacturing process - dose calibrator.  No external contamination detected, including in the lead containment shipping vessel.

Depth of distribution

Healthcare establishment

Affected products