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Dextran 40 in Dextrose injection & Dextran 40 in Sodium Chloride injection - Potential for Crystallization - Notice to Hospitals
- Starting date:
- October 23, 2013
- Posting date:
- October 25, 2013
- Type of communication:
- Notice to Hospitals
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information
- Audience:
- Healthcare Professionals
- Identification number:
- RA-36461
This is duplicated text of a letter from Hospira Healthcare Corporation. Contact the company for a copy of any references, attachments or enclosures.
Notice about Health Canada advisories
NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on 10% LMD in 5% Dextrose Injection, Dextran 40 in Dextrose Injection, USP, 100mg/mL (500mL) & 10% LMD in 0.9% Sodium Chloride Injection, Dextran 40 in Sodium Chloride Injection, USP, 100mg/mL (500mL)
October 23, 2013
Dear Chief of Medical Staff and Director of Pharmacy
Please distribute to relevant Departments (Oncology, Pharmacy, Geriatrics, Internal Medicine, Nursing, Paediatrics, Intensive Care Unit, Coronary Care, Emergency Department, Surgery, Recovery Room and/or other Departments as required), and other involved professional staff and post this Notice in the relevant areas of your institution.
Subject: Potential for Crystallization with Dextran 40 in Dextrose injection & Dextran 40 in Sodium Chloride injection (DIN 00224235 and DIN 00224227)
Hospira Healthcare Corporation, in consultation with Health Canada, would like to inform you that complaints have been received from outside of Canada regarding crystallization in 10% LMD in 5% Dextrose Injection (Dextran 40 in dextrose injection) and 10% LMD in 0.9% Sodium Chloride Injection (Dextran 40 in Sodium Chloride injection). Upon visual inspection of the retained samples, particulate matter was found in one of the retained samples from one lot of Dextran distributed outside Canada. The particulate was identified as crystallized Dextran, which is a known and spontaneous phenomenon associated with Dextran. Although Hospira has not received any complaints regarding lots distributed in Canada, healthcare professionals are being advised of the potential for crystallization.
- Crystallization of product has been identified in several lots of DEXTRAN 40 distributed outside of Canada
- Intravenous administration of crystallized particles could potentially lead to patient harm including venous and/or arterial thromboembolism and death.
- Parenteral drug products should be inspected visually for particulate matter including crystallization and discoloration prior to administration
- Product should not be used if any of the above have occurred
- Hospira Canada is instructing you to infuse concentrated LMD using an administration set that includes a 0.2 micron filter
- Hospira Canada will be updating the Canadian Product Information for Dextran products to include a requirement to infuse this drug using an administration set that contains a filter.
10% LMD 40 (Dextran 40 in Dextrose or Sodium Chloride USP) is indicated:
- As adjunct in the treatment of shock (haemorrhagic, cardiogenic, septic), for expansion of plasma volume and enhancement of blood flow.
- As a priming fluid in pump-oxygenators for perfusion during extracorporeal circulation.
- In impairment of the arterial and venous circulation as in thrombosis, thrombo-phlebitis, imminent gangrene, ulcus cruris (venous ulcers) and Raynaud’s disease.
| Description | DIN |
|---|---|
| 10% LMD in 5% Dextrose Injection, Dextran 40 in Dextrose Injection, USP, 500 mL | 00224235 |
| 10% LMD in 0.9% Sodium Chloride Injection, Dextran 40 in Sodium Chloride Injection, USP, 500 mL | 00224227 |
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious adverse reaction or other serious or unexpected adverse reactions in patients receiving Dextran Injection should be reported to Hospira Healthcare Corporation or Health Canada at the following addresses:
Hospira Healthcare Corporation
1111 Dr.-Frederik-Philips, Suite 600
Saint-Laurent (Québec) H4M 2X6
To report an Adverse Reaction, consumers and health professionals may call toll free :
Tel: 1-866-488-6088 Option 6
Fax: 1-877-906-0208
ProductcomplaintsCA@hospira.com
To correct your mailing address or fax number, contact: Hospira Healthcare Corporation.
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
- Calling toll-free at 1-866-234-2345, or
- Visiting MedEffect Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
For other health product inquiries related to this communication, please contact Health Canada at:
Health and Product and Food Branch Inspectorate (HPFBI)
E-mail: DCVIU_UVECM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636
Sincerely,
original signed by
Rania Al-Ammar
Regional Director, Commercial Quality
Hospira Healthcare Corporation