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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