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Kinevac
- Starting date:
- February 13, 2013
- Posting date:
- March 1, 2013
- 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-23813
Recalled Products
A. Kinevac
Reason
Stability trend data of the Lot C0697A have demonstrated that the unknown impurity specifications upper limit will be reached at 21.3 months and the product is labeled for a shelf life of 24 months.
Depth of distribution
Wholesalers and Hospitals (Nuclear medicine department or establishment buyer/pharmacist)
Affected products
A. Kinevac
DIN, NPN, DIN-HIM
DIN 02228602Dosage form
Lyophilised powder
Strength
5 mcg (1 mcg/mL after reconstitution)
Lot or serial number
C0697A
Companies
- Recalling Firm
-
Bracco Imaging Canada Inc.
11065, Louis H. Lafontaine Blvd.
Anjou
H1J 2Z4
Quebec
CANADA
- Marketing Authorization Holder
-
Bracco Imaging Canada Inc.
11065, Louis H. Lafontaine Blvd.
Anjou
H1J 2Z4
Quebec
CANADA