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Urgent Batch Recall of Clexane Syringes (Enoxaparin Sodium Ph. Eur.) 80mg/0.8ml

Notice type: Recall

Date: 09/02/2006

  

Product name or type:
Clexane Syringes (Enoxaparin Sodium Ph. Eur.) 80mg/0.8ml

Reference:
002/2006

Authorisation Number:
PA 540/97/1

Active Substance:
Enoxaparin Sodium Ph. Eur.

Serial Or Batch Number And Expiry Date:
Batch Number 28043- Expiry Date: 09/07

Authorisation Holder:
Sanofi Aventis

Problem Or Issue:
This is to advise you that Sanofi-Aventis is immediately and urgently recalling to patient, pharmacy and wholesale level Batch No. 28043 of Clexane Syringes, 80mg/0.8ml. 

The reason for the recall is that, with this batch, there is the potential for a significant over-concentration (up to 50%) of the active component (Enoxaparin) in a limited number of syringes. 

This may have severe adverse consequences for patients, particularly patients who are receiving this product for treatment. 

This batch has been in the distribution chain in Ireland since November 22nd, 2005, and has gone to both hospital and retail pharmacies.  

Note: The pharmacies (both Hospital and Retail) which received Clexane Syringes since November 22nd 2005 are being contacted by Sanofi Aventis at this time, starting from the evening of February 9th, by telephone. 

This will be followed by a written recall communication to both pharmacists and prescribing physicians.

Background Information Or Related Documents:
A Questions & Answers document relating to this issue.

Actions To Be Taken:
Hospital Pharmacists and Sisters in Charge at hospitals are immediately requested to do the following: Please immediately identify and quarantine all unused units of this batch which are located within your hospital. If you have dispensed any batch of this product to any out-patient since November 22nd, 2005, please immediately identify these patients, and please contact them as soon as possible to determine if they have Batch Number 28043. If they do have this batch, please advise them to not use this batch, and to return all unused units of this batch to you immediately. 

Please contact Ms. Ella Casey, CMR Dublin, (01-630 5302) who will arrange for the uplift of any units of this batch which you have. If you have supplied this product to any other hospital or pharmacy since November 22nd 2005, please contact the undersigned (Kevin O' Donnell) and that hospital or pharmacy immediately. Replacement stock, which is unaffected by this issue, is available immediately.

Further Information:
HPRA Contact if you require any further information. 

Kevin O' Donnell, 
Market Compliance Manager, 
Health Products Regulatory Authority 
Earlsfort Terrace, 
Dublin 2, 
Ireland 

Tel: +353-1-6764971 (office), 
Tel: +353-87-9562818 (mobile) 
Fax: +353-1-6764061

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