Health Canada
www.hc-sc.gc.ca
Common menu bar links
Voluntary recall of FRAXIPARINE graduated syringes, 0.6 mL and FRAXIPARINE FORTE graduated syringes, 0.8 mL - For Health Professionals
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
(PDF Version - 483 K)Contact DCVIU UVCEM
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional
This is duplicated text of a letter from GlaxoSmithKline Inc.
Contact the company for a copy of any references, attachments or enclosures.
June 5, 2007
Subject: Voluntary recall of FRAXIPARINE® graduated syringes, 0.6 mL and FRAXIPARINE® FORTE graduated syringes, 0.8 mL
Dear Health Care Professional,
GlaxoSmithKline Inc. (GSK) has recently identified a very low occurrence of cracks on the interior of the syringe barrels of FRAXIPARINE® (nadroparin calcium injection, 9500 anti-Xa IU/mL) and FRAXIPARINE® FORTE (nadroparin calcium injection, 19,000 anti-Xa IU/mL) pre-filled graduated syringes. GSK, with agreement from Health Canada, has undertaken a voluntary recall of all lots affected by the problem at the hospital, pharmacy and wholesale level. In Canada, this recall is limited to two specific lots: one lot of FRAXIPARINE® 0.6 mL (Lot no. 3359, Expiry date 03-Nov-2009) and one lot of FRAXIPARINE® FORTE 0.8 mL (Lot no. 1071, Expiry date 06-Sep-2009) pre-filled graduated syringes. As a result, there is the possibility of a temporary supply shortage of these strengths. Non-graduated syringes are not impacted and no other GSK products are impacted by this issue.
The likelihood of receiving a defective syringe is very low; out of approximately 10 million potentially affected syringes, approximately 20 occurrences of broken graduated syringes have been reported globally to date. There have been no complaints reported in Canada. Two potential consequences of encountering a defective syringe have been identified. Breakage of the syringe prior to or during injection could occur, which may cause injury during administration. In addition, there is a potential, but small, risk to sterility should the crack propagate over the shelf life of the product. While the overall risk to patients and healthcare professionals is low, GSK has decided to voluntarily recall all affected batches at the hospital, pharmacy and wholesale level. A Public Advisory will be issued and patients will be advised to contact their physician for alternative treatment options and to return any affected product to their pharmacist.
Prescribers
- Due to a temporary shortage of these strengths, physicians may need to consider alternative treatment options for patients currently receiving FRAXIPARINE® 0.6 mL or FRAXIPARINE® FORTE 0.8 mL pre-filled graduated syringes or when initiating treatment in new patients who may require these dosage strengths.
- When considering unfractionated heparin or other low molecular weight heparins (LMWHs) as alternative treatments, physicians are reminded that FRAXIPARINE®/FRAXIPARINE® FORTE cannot be used interchangeably (unit for unit) with unfractionated heparin or LMWHs as they differ in their manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units and dosages. Special attention and compliance with instructions for use of each specific product is required during any change in treatment.
- If you initiate patient therapy in your office or clinic and discover any cracked syringes or have the above-mentioned lots in your office, please contact GSK immediately at 1-800-387-7374.
- All pharmacies, hospitals and wholesalers have been sent a communication regarding the affected FRAXIPARINE® and FRAXIPARINE® FORTE lots in order to address the recall.
Pharmacists
- Pharmacists should follow instructions as per the Product Recall Notice issued by GSK on Friday May 25, 2007.
Due to the purchase of certain product lines by GlaxoSmithKline, Sanofi-Synthelabo appears as the manufacturer on the affected product lots.
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-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of syringe cracking or breakage or any serious or unexpected adverse reactions in patients receiving FRAXIPARINE® or FRAXIPARINE® FORTE should be reported to GlaxoSmithKline or Health Canada at the following addresses:
7333 Mississauga Road
Mississauga, Ontario L5N 6L4
Tel: 1-800-387-7374
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866-234-2345
Fax: 866-678-6789
cadrmp@hc-sc.gc.ca
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
For other inquiries related to this communication, please contact Health Canada at:
Health Products and Food Branch Inspectorate - Drug Compliance Verification and Investigation Unit (DCVIU)
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Tel: 613-941-3967
Fax: 613-952-9805
GSK remains committed to product quality and patient safety and is working expeditiously to resume normal supply. Should you have any questions or require any additional information regarding the recall of FRAXIPARINE® and FRAXIPARINE® FORTE, please contact GSK customer service at 1-800-387-7374.
Sincerely,
original signed by
Ravinder Kumar, Ph.D.
Vice-President, Regulatory Affairs
GlaxoSmithKline Inc.
FRAXIPARINE ® and FRAXIPARINE ® FORTE are registered trademarks, used under license by GlaxoSmithKline Inc.
