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Solu-CORTEF 100 mg Act-O-Vial (2016-07-22)
- Starting date:
- July 22, 2016
- Posting date:
- August 3, 2016
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- Healthcare Professionals, Hospitals, General Public
- Identification number:
- RA-59678
Affected products
Solu-CORTEF 100 mg Act-O-Vial
Reason
Label text error on the side panel of the carton which indicates that the reconstitued product contains 125 mg/mL hydrocortisone instead of 50 mg/mL.
Depth of distribution
Wholesalers and pharmacies across Canada
Affected products
Solu-CORTEF 100 mg Act-O-Vial
DIN, NPN, DIN-HIM
DIN 00030600
Dosage form
Powder for solution
Strength
100 mg/vial
Lot or serial number
L42719
L58373
L58374
M41003
M63458
N15764
N54056
N62805
Companies
- Recalling Firm
-
Pfizer Canada Inc.
17300 Trans-Canada Hwy.
Kirkland
H9J 2M5
Ontario
CANADA
- Marketing Authorization Holder
-
Pfizer Canada Inc.
17300 Trans-Canada Hwy.
Kirkland
H9J 2M5
Ontario
CANADA