Class 3 Medicines Recall: Sildenafil 100mg Film-coated Tablets (Strandhaven Limited T/A Somex Pharma)

Drug alert number: EL(23)A/21

Date issued: 3 July 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 3 medicines recall for: Sildenafil 100mg Film-coated Tablets (Strandhaven Limited T/A Somex Pharma) – PL 15764/0043

SNOMED Code: 326715008

*Mislabelled packs indicate 8 tablets

Active Pharmaceutical Ingredient: Sildenafil Citrate

Brief description of the problem

Strandhaven Limited T/A Somex Pharma has informed the MHRA that the pack size on some cartons of the batch in this notification state 8 tablets instead of 4 tablets. This is an error due to cartons being mixed at the printers. All cartons with batch number ET22028 contain one blister strip of 4 tablets regardless of whether it states 8 tablets or 4 tablets on the pack.

Only the batch listed in this notification is affected. Due to the low number of complaints received, only the packs labelled as containing 8 tablets are being recalled at this time. The batch is comprised of 60340 packs, to date 195 packs have been found to be mislabelled.

The quality and safety of the tablets is not impacted and therefore this is not a patient level recall.

Advice for healthcare professionals

Strandhaven Limited T/A Somex Pharma ask that healthcare professionals stop supplying and quarantine any stock with this batch number that is labelled as containing 8 tablets. Return these packs through your approved process.

The packs labelled as 4 tablets, can be dispensed as normal. The quality and safety of the tablets is not impacted and therefore this is not a patient level recall.

For Patients that were already prescribed 8 tablets and have received one pack of this batch (the patient will have received only 4 tablets). Should the patient raise a complaint:

• For prescriptions written within the last 6 months, check the pack being returned by the patient and the dispensing record (Summary Care Record may be checked with the patient’s consent) to confirm there was an error and dispense a further 4 tablets. Following advice from the Department of Health and Social Care, this is considered a correction to the original prescription and a further prescription would not be necessary. Follow your company’s returns procedure through your wholesaler to arrange a credit note or contact SomexPharma to arrange the supply of the additional 4 tablets or credit note (see Further Information section) for further details.

Full drug alert can be viewed here.

Further Information

For medical information enquiries please contact email: regulatory@somexpharma.com, Tel: 020 8590 9399, choose option 3 or 4.

For stock control enquiries please contact email: regulatory@somexpharma.com, Tel: 020 8590 9399, choose option 3 or 4.