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MHRA recalls Ramipril 10mg capsules over wrong dose

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MHRA recalls Ramipril 10mg capsules over wrong dose
Key Points
  • MHRA recalls Ramipril 10mg capsules batch GR174091 due to potential wrong dose
  • Patients advised to check packaging and contact pharmacy if blister strips are labelled 5mg
  • Risk of taking lower dose for short time is very low, but adverse effects should be reported

The recall was issued by the MHRA after it was discovered that some cartons of Ramipril 10mg capsules may contain blister strips labelled as Ramipril 5mg capsules. Both product batches were manufactured at the same site, and the error occurred during secondary packaging of the cartons, according to multiple reports.

The MHRA has advised pharmacy and healthcare professionals to stop supplying the impacted batch and return all remaining stock to suppliers. Dr Alison Cave, MHRA chief safety officer, said: "If you take Ramipril 10mg, check the packaging for batch number GR174091. The batch number and expiry date information can be found on the outer carton." She added: "If you have received this batch, check that the medication name on the carton matches the blister strips inside."

If you take Ramipril 10mg, check the packaging for batch number GR174091. The batch number and expiry date information can be found on the outer carton.

Dr Alison Cave, MHRA chief safety officer

Ramipril is used to treat high blood pressure, heart failure, and after a heart attack. The medication helps prevent strokes, heart attacks, and kidney problems by widening blood vessels. Both strengths of the medication are used to treat high blood pressure, heart failure, and kidney disease.

The MHRA has stated that the risk to patients taking the lower dose for a short time is very low. Any possible impact of a lower dose is expected to be gradual rather than immediate or life threatening. Patients experiencing adverse effects after taking the lower dose are urged to seek medical advice. Dr Cave advised: "If the 10 mg carton of Ramipril contains blister strips that are labelled as Ramipril 5mg capsules, contact your dispensing pharmacy." She also noted: "If the carton contains blister strips that are correctly labelled as Ramipril 10mg capsules, you do not need to take further action."

If you have received this batch, check that the medication name on the carton matches the blister strips inside.

Dr Alison Cave, MHRA chief safety officer

The usual starting dose of Ramipril is between 1.25mg and 2.5mg once a day, with a maximum dose of 5mg twice a day or 10mg once a day. It remains unclear how many patients have been affected by the error or how widespread the distribution of the affected batch is. The specific batch number for the 5mg capsules that were incorrectly packaged has not been disclosed, and Crescent Pharma Limited has not yet identified the root cause of the manufacturing error.

If the 10 mg carton of Ramipril contains blister strips that are labelled as Ramipril 5mg capsules, contact your dispensing pharmacy.

Dr Alison Cave, MHRA chief safety officer

If the carton contains blister strips that are correctly labelled as Ramipril 10mg capsules, you do not need to take further action.

Dr Alison Cave, MHRA chief safety officer
Corroborated
The Independent - MainDaily Mail - HealthGB News
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