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Health product recall

Iobenguane I123 injection (2016-04-28)

Starting date:
April 28, 2016
Posting date:
May 13, 2016
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-58304

Affected Products

Iobenguane I123 injection

Reason

Recall initiated because the product does not meet the specification results for purity.

Depth of distribution

Hospitals (Clinic)

Affected products

Iobenguane I123 injection

DIN, NPN, DIN-HIM

Not applicable

Dosage form

Liquid

Strength

Assay -63.81Mbq/ml

Lot or serial number

#12516, Rx#171256

Companies
Recalling Firm

Edmonton Radiopharmaceutical Centre

11560 University Avenue

Edmonton

T6G 1Z2

Alberta

CANADA

Marketing Authorization Holder

Not Applicable