Class 4 Medicines Defect Information: Strandhaven Ltd t/a Somex Pharma

Source: MHRA /

Patient Information Leaflets (PILs) have been identified in several batches of the following Strandhaven Limited t/a Somex Pharma lines:

Advice for healthcare professionals

There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the products and where possible, provide an updated PIL. The updated PIL is available electronically and can be downloaded from the Somex Pharma Website. If it is not possible to provide an updated PIL, please advise patients of the missing information, discuss if this medicine is still suitable for them, and the need to seek medical advice if these signs or symptoms occur.

Strandhaven Limited t/a Somex Pharma has confirmed that all future batches will contain the correct PIL. Upon request, Strandhaven Limited t/a Somex Pharma will post hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information (see contact details below).