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Heparin Sodium in 5% Dextrose Injection, 25000 unit / 500 ml / (March 25, 2008)

Starting date:
March 25, 2008
Posting date:
April 14, 2008
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-2008A37

Reason

Some API lots of Heparin Sodium were found to be contaminated with a heparin-like contaminant. As a precautionary measure, all lots that may have been affected by this contamination are being recalled.

Depth of distribution

Product is distributed to wholesalers and hospitals throughout Canada. Product is not exported.

Affected products

Heparin Sodium in 5% Dextrose Injection, 25000 unit / 500 ml /

DIN, NPN, DIN-HIM

DIN 01935941

Dosage form

Solution

Strength

  • Heparin Sodium 5000 unit / 100 mL
  • Dextrose 5 g / 100 mL
  • Citric Acid 93 mg / 100 mL
  • Sodium Phosphate Dibasic 410 mg / 100 mL

Lot or serial number

J7E577, J6L669, J5S669

Companies

Recalling Firm
B. Braun Medical Inc.
2000 Ellesmere Rd., Unit 16
Scarborough Ontario
Canada M1H 2W4
Marketing Authorization Holder
B. Braun Medical Inc.
901 Marcon Blvd.
Allentown Pennsylvania
United states ÉTATS-UNIS 18109