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Sabril, Sereflo Ciphaler, Kelhale, Icatibant, Grepid safety notices

Two recalls; four alerts

July 14th 2023

Tagged: MHRA alert


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 numberExpiry datePack sizeFirst distributed
2989AApril 202510002/08/22
2988DApril 202510015/07/22
2006BNovember 202510015/03/23

Sabril 500 mg granules for oral solution

Batch numberExpiry datePack sizeFirst distributed
1994AMay 20245015/09/21
2028BMarch 20255030/08/22

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:

  • Sereflo Ciphaler 50 microgram/250 microgram/dose Inhalation powder, Pre-Dispensed BP (Fluticasone Propionate & Salmeterol xinafoate)
  • Kelhale 50 and 100 micrograms per actuation pressurised inhalation solution, Beclometasone dipropionate anhydrous
  • Icatibant 30 mg solution for injection in pre-filled syringe
  • Grepid 75 mg film coated tablets (Kent Pharma Livery) (clopidogrel)

Affected batches are not being recalled. Affected batch information is available online.