Medicine recall 9 November 2015

Primidone SERB 50mg tablets – error on the carton

Yes – this has been recalled
The problem
(Laboratoire SERB) EAN barcode is incorrect – when scanned, it identifies the product as Primidone SERB 250mg tablets not 50mg tablets (EL (15)A/10)
What to do
Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.
Source: Medicines and Healthcare products Regulatory Agency (MHRA) Official notice ↗

9 November 2015

Class 4 caution in use

Distribute to pharmacy and wholesaler level

MDR 76-10/15

Product details

Laboratoire SERB

Primidone SERB 50mg tablets

PL 26080/0002

  • Batch number: 530689
    • Expiry date: Nov 2019
    • Pack size: 1 x 100
    • Livery: Laboratoire SERB
    • First distributed: 6 Oct 2015
  • Batch number: 531203
    • Expiry date: Jul 2020
    • Pack size: 1 x 100
    • Livery: Laboratoire SERB
    • First distributed: n/a
  • Batch number: 531299
    • Expiry date: Aug 2020
    • Pack size: 1 x 100
    • Livery: Laboratoire SERB
    • First distributed: n/a

Alert details

Actavis UK Ltd, distributor of the above product, has notified us of an error on the carton. The EAN barcode is incorrect – when scanned, it identifies the product as Primidone SERB 250mg tablets, not 50mg tablets as it should. The strength of the tablets is stated correctly in all positions on the carton where it is readable. There is no risk to product quality or patient safety resulting from this error.

In order to avoid product shortages which could impact on current advice not to switch between different manufacturers for this product, batch 530689 is not being recalled. Two further batches, 531203 and 531299 will also need to be distributed in order to keep the market supplied while the error is corrected.

For stock control queries please contact Actavis Customer Services Team on 0800 373573.

For any medical information enquires please contact the Medical Information Department by emailing enquiries@medinformation.co.uk.

Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.

Download document

Primidone SERB 50mg tablets – error on the carton

Updated 9 November 2015. This page summarises an official notice. Details can change – always follow the official notice.

Website built by: www.NocturnalMedia.co.uk