Heparin sodium in 5% Dextrose injection; Out of specification
Last updated
Summary
Product
Heparin Sodium in 5% Dextrose injection 25000 unit / 500 mL
Issue
Health products - Product quality
What to do
Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concerns.
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot number |
|---|---|---|---|---|---|
| B. Braun Medical Inc | Heparin Sodium in 5% Dextrose injection 25000 unit / 500 mL | DIN 01935941 | Solution | Citric acid 93 mg / 100mL Dextrose 5 g / 100mL Heparin sodium 5000 unit / 100mL Sodium phosphate dibasic 410 mg / 100mL | J2E209N |
Issue
The Anti-Factor Ila potency is out of specification in the affected lot.
What you should do
- Verify if your product is affected.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
Similar recalls or alerts
Additional information
Background
Depth of recall: Wholesalers, Retailers, Healthcare establishments, Users
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
B. Braun Medical Inc
2000 Ellesmere Road, Unit 16,
Scarborough ON M1H 2W4 Canada
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-73658
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