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MHRA issues defect notice for hyoscine butylbromide batch

Pharmacy News

MHRA issues defect notice for hyoscine butylbromide batch

The MHRA has issued a class 4 medicines defect notice for a batch of Morningside Healthcare’s hyoscine butylbromide 20mg film-coated tablets.  

The notice comes after some packs in batch number 2237001 – which consists of 100-size packs, expires in April 2025 and was first distributed on September 28 – were found to contain a product information leaflet for midodrine hydrochloride tablets.

“Healthcare professionals should note that there is no risk to product quality and efficacy, therefore the affected batch is not being recalled,” said the regulator.

It said pharmacists should “exercise caution” when dispensing the affected batch, removing and destroying any incorrect PILs and providing the correct PIL to the patient.

Pharmacies and wholesalers can request hard copies of the hyoscine butylbromide PIL from the manufacturer.

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