Certain individuals prescribed ramipril for high blood pressure are being advised to check for specific symptoms following a packaging error that may have led to incorrect dosages. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on what to look out for and when to seek medical help, as the mistake could pose a greater risk for some patients.
Recall Details
Crescent Pharma Limited is recalling one batch of ramipril 2.5mg capsules as a precautionary measure due to a packaging error. This error may mean that some cartons contain blister strips of a higher dose, specifically ramipril 10mg. The issue came to light after a healthcare professional found two blister strips of ramipril 10mg capsules inside a sealed carton of the 2.5mg product. Both batches were manufactured at the same site, and the error appears to have occurred during packaging.
Approximately 35 million prescriptions for ramipril are issued across pharmacies in England each year. While only one batch is affected, all users are urged to check their medication details and take action if they have the impacted batch.
What to Check
The affected batch number is GR155023. Patients should look for this number on the outer carton. If the carton contains blister strips labelled as ramipril 10mg capsules, they should not take the medicine and contact their dispensing pharmacy. If the blister strips are correctly labelled as 2.5mg, no further action is needed, and patients should continue taking their medication as usual.
Symptoms to Watch For
Dr Alison Cave, MHRA Chief Safety Officer, stated: "Signs and symptoms may include feeling lightheaded, fainting or being fatigued, or altered kidney function and may be more serious for vulnerable patients." She advised anyone who has taken a higher dose and is experiencing side effects to seek medical advice. Any potential impact should be assessed by a healthcare professional to determine if tests are needed.
Previous Recall
This is not the first ramipril recall in recent weeks. In April, Crescent Pharma Limited recalled a separate batch (GR174091) of ramipril 10mg capsules after a blister pack of 5mg was found inside a sealed carton. In that case, patients were advised that the effect of a lower dose was expected to be gradual rather than immediate or life-threatening.
Patients with affected packs are advised to take the leaflet and any remaining tablets to their pharmacy or GP practice. Suspected side effects should be reported via the MHRA Yellow Card scheme.
