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Kogenate FS (with Vial Adapter) (2016-07-25)
- Starting date:
- July 25, 2016
- Posting date:
- July 27, 2016
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-59580
Affected products
Kogenate FS (with Vial Adapter)
Reason
Out of specification result for potency of the active ingredient during shelf-life testing.
Depth of distribution
Hospitals and healthcare facilities (clinics) across Canada except Quebec
Affected products
Kogenate FS (with Vial Adapter)
DIN, NPN, DIN-HIM
DIN 02302217Dosage form
Lyophilized Powder for Injection or Continuous Infusion
Strength
2000 units/vial
Lot or serial number
- 270RH0P
- 270TN19
Companies
- Recalling Firm
-
Bayer Inc.
2920 MATHESON BLVD. EAST
MISSISSAUGA
L4W 5R6
Ontario
CANADA
- Marketing Authorization Holder
-
Bayer Inc.
2920 MATHESON BLVD. EAST
MISSISSAUGA
L4W 5R6
Ontario
CANADA