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Recall notice for Sabril 500mg film-coated tablets, PA 540/23/1

Notice type: Recall

Date: 13/07/2023

 We wish to advise you that batch no. 2006B of Sabril 500mg film-coated tablets, PA 540/23/1 is being recalled with immediate effect.

This recall is to pharmacy level.

The recall has been initiated, as a precaution, due to the presence of trace amounts of the impurity tiapride.

Wholesalers can download a copy of the wholesale recall letter.
Pharmacist can download a copy of the pharmacy recall letter.

As the recall is to pharmacy level, patients are not required to take any actions. 

Product name or type:
Sabril 500mg film-coated tablets

Authorisation Number:
PA 540/23/1

Serial Or Batch Number And Expiry Date:
Batch no.2006B, Expiry date: 11.2025

Authorisation Holder:
Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Recall Classification:
Pharmacy level recall

Target Audience:
Pharmacists and Wholesalers

Actions To Be Taken:
Information for pharmacists:
Pharmacists are requested to carry out the following actions:
1. Immediately identify and quarantine any units from the batch in your facility. For hospital pharmacies, this includes units at wards, clinics and any other relevant locations within the hospital.
2. If you have supplied packs from this batch to any other pharmacy, clinic or other such establishment, please forward a copy of the recall letter to them, and request they quarantine and return any units in their possession to you.
3. Return all quarantined and returned units to your wholesaler. 

Information for wholesalers: 
Wholesalers are requested to carry out the following actions: 
1. Immediately identify and quarantine any units of the batch, which you have in your possession or are returned to you.
2. Identify whether you have supplied units from this batch to any other wholesaler. If you have done so, please forward a copy of this recall letter to those wholesalers, requesting that they immediately quarantine and return any unsold quantities of this batch to you.
3. Return all quarantined and returned units to Allphar before 31 Jul 2023. 

Information for patients:
If you are using this product and have any queries, please contact your pharmacist.

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