News » MHRA alert » Sabril, Sereflo Ciphaler, Kelhale, Icatibant, Grepid safety notices
July 14th 2023
Aventis Pharma Limited (t/a Sanofi) is recalling five batches of two lines of Sabril (vigabatrin)
The affected batches are:
Sabril 500 mg film-coated tablets
| Batch number | Expiry date | Pack size | First distributed |
| 2989A | April 2025 | 100 | 02/08/22 |
| 2988D | April 2025 | 100 | 15/07/22 |
| 2006B | November 2025 | 100 | 15/03/23 |
Sabril 500 mg granules for oral solution
| Batch number | Expiry date | Pack size | First distributed |
| 1994A | May 2024 | 50 | 15/09/21 |
| 2028B | March 2025 | 50 | 30/08/22 |
Affected batches are being recalled as a precautionary measure due to the detection of traces of tiapride in source material, an ingredient not licensed for use in the UK.
Tiapride is indicated for the treatment of a variety of neurological and psychiatric disorders including dyskinesia, alcohol withdrawal syndrome, negative symptoms of psychosis, and agitation and aggression in the elderly.
Sanofi says there is a potential risk to children who may have or are taking the impacted batches of Sabril tablets or Sabril granules. Dispensary teams are asked to immediately contact all affected patients under 17 to ask them to return affected batches to the prescriber for review and alternative prescription.
Patients under 17 and their guardians should be advised to continue treatment until they are reviewed.
Adults do not need to present for review or replacement prescriptions.
Healthcare professionals are asked to quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Sereflo Ciphaler, Kelhale, Icatibant, Grepid
Cipla (EU) Limited and Pharmathen SA have issued an alert over several batches of several products that are missing the acronym ‘POM’ from the outer carton.
The affected products are:
Affected batches are not being recalled. Affected batch information is available online.
