Class 3 Medicines Recall: Tamoxifen 20mg Film-Coated Tablets, Wockhardt UK Ltd, EL(25)A/31

Wockhardt UK Limited is recalling a batch as a precautionary measure following the identification of a dissolution failure during stability testing.

DMRC Number: DMRC-35980389

Company name:Wockhardt UK Ltd

Product description: 

Tamoxifen 20mg Film-Coated Tablets

PL: 29831/0195

Active ingredient: tamoxifen citrate

SNOMED code: 659711000001107

Details of the affected batch:

Brief description of problem: 

Wockhardt UK Limited is recalling the above batch as a precautionary measure following the identification of a dissolution failure during stability testing.

Advice to Healthcare Professionals: 

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Advice to Patients: 

Patients should continue to take medicines as prescribed by your healthcare professional. The recall is being actioned at the pharmacy and wholesaler level as a precautionary measure. No complaints of harm or lack of efficacy have been received from patients regarding this batch.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information: 

For medical information enquiries please email drug.safety@wockhardt.co.uk, or telephone 01978 661261 and ask for ‘drug safety’.

For stock control enquiries please email group_uk_csu@wockhardt.co.uk, or telephone 01978 661261and ask for ‘customer services’.

Access the full recall