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MHRA recalls Sildenafil 100mg film-coated tablets

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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).

Manufacturer of drug, Strandhaven Limited T/A Somex Pharma has informed the MHRA that the pack size on some cartons of the batch 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 number ET22028 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.

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).

SNOMED Code: 326715008

Batch No Expiry Date Pack Size First Distributed
ET22028 02/2025 4 tablets* 16.01.2023

*Mislabelled packs indicate 8 tablets

 

 

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