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Health product recall

DraxImage Sestamibi (2016-10-14)

Starting date:
October 14, 2016
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-60734

Affected Products

Reason

Out of specification result for the oxygen content during stability testing.

Depth of distribution

Hospitals across Canada

Affected products

DraxImage Sestamibi

DIN, NPN, DIN-HIM
Not Applicable
Dosage form

Powder for solution

Strength

1 mg / vial of Tetrakis [CU(MIB)4BF4]

Lot or serial number

5H021A

Companies
Recalling Firm
Jubilant Draximage Inc
16751 Trans-Canada Highway
Kirkland
H9H 4J4
Quebec
CANADA
Marketing Authorization Holder
Jubilant HollisterStier Contract Manufacturing & Services
16751 Trans Canada Highway
Kirkland
H9H 4J4
Quebec
CANADA

Date modified: