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Health product recall

[Tc-99m]-Gluceptate (2017-10-06)

Starting date:
October 6, 2017
Posting date:
October 18, 2017
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-64874

Affected products

[Tc-99m]-Gluceptate

Reason

Sterility is out of specification.

Note: Company investigation concluded no microbial contamination or product quality issue.

Depth of distribution

Medical Centre located in Hamilton, Ontario, Canada

Affected products

[Tc-99m]-Gluceptate

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

Liquid

Strength
  • 0.36 GBq (lot M-170926GLUCO-1)
  • 0.58 GBq (lot M-170927GLUCO-1)
Lot or serial number
  • M-170926GLUCO-1
  • M-170927GLUCO-1
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

Date modified: