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Another Class 4 Alert

The MHRA has just posted another Class 4 Alert relating to the patient information leaflet (PIL) of Timoptol-LA 0.25% w/v & 0.5% w/v Gel-Forming Eye Drops Solutions.

The dose printed on the PIL is wrong. It states a dose of twice a day instead of the correct ONCE a day dosage.

The batches affected are on the MHRA website ( link ). These batches have not been recalled to ‘avoid stock disruption’.

Our advise will be to amend the PIL accordingly. Merck Sharp and Dohme Limited have moved to correct this error but we cannot help but wonder the LFL (Like for Like) figures for Class 4 alerts. Are they becoming increasingly frequent?

A little research project for a student of pharmacy perhaps?


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