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Health product recall

IGIVnex (2012-02-25)

Starting date:
February 25, 2014
Posting date:
March 14, 2014
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-38225

Recalled products

  1. IGIVnex

Reason

Precautionary measure due to an apparent higher rate of expected adverse reactions

Depth of distribution

Hospitals in Newfoundland and Labrador, Nova Scotia, Ontario, Manitoba, Saskatchewan, Alberta, British Columbia via Canadian Blood Services

Affected products

  1. IGIVnex

DIN, NPN, DIN-HIM

DIN 02277921

Dosage form

Solution for Injection

Strength
  • 10% 10g/100mL
Lot or serial number
  • 26NP0R1
Companies
Recalling Firm

Grifols Canada Ltd

5060 Spectrum Way, Suite 405

Mississauga

L4W 5N5

Ontario

CANADA

Marketing Authorization Holder

Grifols Therapeutics Inc.

8368 US 70 Bus Hwy W

Clayton

27520

North Carolina

UNITED STATES