Health product recall

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

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

Fludeoxyglucose (18F) Injection

DIN, NPN, DIN-HIM

DIN 02412837

Dosage form

Solution

Strength

Fludeoxyglucose 0.5 GBq / 16 mL

Lot or serial number

G20200316

Companies

Recalling Firm

Winnipeg Regional Health Authority

710 William Avenue

Winnipeg

R3B 1E2

Manitoba

CANADA

Marketing Authorization Holder

Winnipeg Regional Health Authority

650 Main Street, 4th Floor

Winnipeg

R3B 1E2

Manitoba

CANADA