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Health product recall

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