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Health product recall

18 F- Fluorodeoxyglucose (2017-01-24)

Starting date:: January 24, 2017
Posting date:: February 22, 2017
Type of communication:: Drug Recall
Subcategory:: Drugs
Hazard classification:: Type III
Source of recall:: Health Canada
Issue:: Product Safety
Audience:: General Public, Healthcare Professionals, Hospitals
Identification number:: RA-62312

Reason
Affected products

Reason

Sterility testing did not meet specifications for the affected lots.

Affected products

18 F- Fluorodeoxyglucose

DIN, NPN, DIN-HIM

No market authorization

Dosage form

Liquid

Strength

65.2 Gbq (F01717)

72.4 Gbq (F01817)

59.1 Gbq (F02317)

12.2 Gbq (F02517)

47.2 Gbq (F03217)

76.6 Gbq (F03317)

72.8 Gbq (F03517)

FluGlucoScan Injection

Lot or serial number

F01717

F01817

F02317

F02517

F03217

F03317

F03517

Companies

Recalling Firm

Edmonton Radiopharmaceutical Centre

11560 University Avenue

Edmonton

T6G 1Z2

Alberta

CANADA

Marketing Authorization Holder