Primidone SERB 50mg tablets - error on the carton
- Medicines and Healthcare products Regulatory Agency
- 9 November 2015
- 9 November 2015
- Alert type:
- Drug alert
- Medical speciality:
(Laboratoire SERB) EAN barcode is incorrect – when scanned, it identifies the product as Primidone SERB 250mg tablets not 50mg tablets (EL (15)A/10)
9 November 2015
Class 4 caution in use
Distribute to pharmacy and wholesaler level
Primidone SERB 50mg tablets
|Batch number||Expiry date||Pack size||Livery||First distributed|
|530689||Nov 2019||1 x 100||Laboratoire SERB||6 Oct 2015|
|531203||Jul 2020||1 x100||Laboratoire SERB||n/a|
|531299||Aug 2020||1 x 100||Laboratoire SERB||n/a|
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 email@example.com.
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.
Published: 9 November 2015
Issued: 9 November 2015
Alert type: Drug alert
Medical speciality: Pharmacy