|Title:||Clexane® (Enoxaparin injection) Recall|
|Document ID:||Operational Directive OD 0117/08|
|Date of issue:||Friday, 16 May 2008|
|Status:||NO LONGER APPLICABLE|
|Description:||On 22 April 2008, the Therapeutic Goods Agency initiated a recall of contaminated batches of Enoxaparin. This Operational Directive outlines the hospital management of both contaminated and uncontaminated batches, and the stock level reporting requirements of all heparin products.|
|Applicable to:||All staff.|
|Period of effect:||from 16 May 2008 to 31 December 2008|
|Review date:||31 December 2008|
|Authorised by:||Dr. Peter Flett, ACTING DIRECTOR GENERAL, WA HEALTH, 15-May-2008|
|Print version:||View print version|
Clexane® (Enoxaparin injection) Recall
On 22 April 2008, Sanofi Aventis recalled five batches of Clexane® (Enoxaparin). The batches recalled are:
REASON FOR RECALL
On 22 April 2008, the Therapeutic Goods Agency notified States and Territories that a number of batches of Clexane®, which contained measurable levels of the contaminant, over-sulphated chondroitin sulphate (OSCS), had been released to the Australian market.
The presence of OSCS has been associated with the occurrence of anaphylactic reactions in the United States and Germany, including a number of deaths. There has been no increase in reports of similar anaphylactic reactions in patients receiving Clexane® in Australia.
There are limited stocks of enoxaparin injection and other low molecular weight heparin (LMWH) products available both within the state and nationally. To limit the impact of the Clexane® recall, until further stock becomes available, the following actions are to be taken by all hospitals and Health facilities:
· All of the recalled batches of Clexane® are to be quarantined in the hospital pharmacy. Further consolidation of quarantined supplies may occur in future.
· All stock of LMWH (Clexane®, Fragmin®) are to be retrieved from wards and consolidated in the hospital pharmacy to be released on a clinical need basis.
· All hospitals are to report the stock levels of all heparin products weekly (Friday) through their pharmacy to the Pharmacy Branch within the Public Health Division.
The Department of Health and Ageing (DOHA) is currently finalising national Clinical Guidelines. These will form the basis for a future Operational Directive that will guide WA Health use of heparin products in the advent of future shortages of heparin products.
Dr. Peter Flett
This circular last updated: Friday, 16 May 2008 at 10:21am