Health product recall

Baxter Canada product recall (2019-09-23)

Starting date:
September 23, 2019
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72511

Last updated: 2020-03-06

Summary

  • Product:
    1. Ifex (Ifosfamide) 1 g powder for solution
    2. Ifex (Ifosfamide) 3 g powder for solution
    3. Procytox 200 mg powder for solution
    4. Procytox 500 mg powder for solution
    5. Procytox 1000 mg powder for solution
    6. Procytox 2000 mg powder for solution
    7. Procytox 50 mg tablet
    8. Tisseel Kit
  1. Ifex (Ifosfamide) 1 g powder for solution
  2. Ifex (Ifosfamide) 3 g powder for solution
  3. Procytox 200 mg powder for solution
  4. Procytox 500 mg powder for solution
  5. Procytox 1000 mg powder for solution
  6. Procytox 2000 mg powder for solution
  7. Procytox 50 mg tablet
  8. Tisseel Kit

Reason

Affected lots may have been exposed to temperatures outside of the recommended storage conditions.

Depth of distribution

Retailers

Affected products

A. Ifex (Ifosfamide) 1 g powder for solution

DIN, NPN, DIN-HIM

DIN 02241357

Dosage form

Powder For Solution

Strength

Ifosfamide 1 g/vial

Lot or serial number

8K090J

Companies

Recalling Firm
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA
Marketing Authorization Holder
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA

B. Ifex (Ifosfamide) 3 g powder for solution

DIN, NPN, DIN-HIM

DIN 02241356

Dosage form

Powder for solution

Strength

Ifosfamide 3 g/vial

Lot or serial number

8G016F

Companies

Recalling Firm
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA
Marketing Authorization Holder
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA

C. Procytox 200 mg powder for solution

DIN, NPN, DIN-HIM

DIN 02241797

Dosage form

powder for solution

Strength

Cyclophosphamide 200 mg/vial

Lot or serial number

8G250C

Companies

Recalling Firm
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA
Marketing Authorization Holder
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA

D. Procytox 500 mg powder for solution

DIN, NPN, DIN-HIM

DIN 02241798

Dosage form

powder for solution

Strength

Cyclophosphamide 500 mg/vial

Lot or serial number

8K107A

Companies

Recalling Firm
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA
Marketing Authorization Holder
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA

E. Procytox 1000 mg powder for solution

DIN, NPN, DIN-HIM

DIN 02241799

Dosage form

powder for solution

Strength

Cyclophosphamide 1000 mg/vial

Lot or serial number

8L181E

Companies

Recalling Firm
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA
Marketing Authorization Holder
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA

F. Procytox 2000 mg powder for solution

DIN, NPN, DIN-HIM

DIN 02241800

Dosage form

powder for solution

Strength

Cyclophosphamide 2000 mg/vial

Lot or serial number

9A023B

Companies

Recalling Firm
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA
Marketing Authorization Holder
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA

G. Procytox 50 mg tablet

DIN, NPN, DIN-HIM

DIN 02241796

Dosage form

tablet

Strength

Cyclophosphamide 50 mg

Lot or serial number

9A015E

Companies

Recalling Firm
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA
Marketing Authorization Holder
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA

H. Tisseel Kit

DIN, NPN, DIN-HIM

DIN 02326132

Dosage form

Kit

Strength

  • Aprotinin (synthetic) 3000 KIU/mL
  • Calcium chloride 40 mcmol/mL
  • Sealer protein (human) 125 mg/mL
  • Thrombin (Human) 500 unit/mL

Lot or serial number

T5T042AG, TSU008AB

Companies

Recalling Firm
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA
Marketing Authorization Holder
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA