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[Tc-99m]-Bicisate (2017-09-22)
- Starting date:
- September 22, 2017
- Posting date:
- October 6, 2017
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-64804
Affected products
[Tc-99m]-Bicisate
Reason
The sterility may be out of specification in the affected lots.
Note: Company investigation concluded no microbial contamination or product quality issue.
Depth of distribution
3 Hospitals located in Hamilton, Ontario, Canada
Affected products
[Tc-99m]-Bicisate
DIN, NPN, DIN-HIM
No market authorization
Dosage form
Liquid
Strength
2.45 and 1.24 GBq
Lot or serial number
M-170830BIC-1
M-170905BIC-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