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Health product recall

Glucovision (2014-06-19)

Starting date:
June 19, 2014
Posting date:
July 11, 2014
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-40377

Recalled Products

Glucovision

Reason

Out of specification result for sterility test.

Depth of distribution

1 hospital and 1 clinic in Ontario

Affected products

Glucovision

DIN, NPN, DIN-HIM
No market authorization
Dosage form

Glass Vials

Strength

37 [F-18]-Fludeoxyglucose (FDG) Phosphate/vial

Lot or serial number

140616FDG-2

Companies
Recalling Firm
Centre for Probe Development and Commercialization (CPDC)
1280 Main St. W. NRB-A316
Hamilton
L8S 4K1
Ontario
CANADA
Marketing Authorization Holder
Not Applicable