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Crescent Pharma Limited is recalling one batch of Ramipril 2.5mg capsules as a precautionary measure due to a packaging error which may mean some cartons contain blister strips of a higher dose, specifically Ramipril 10mg.
This follows a complaint which identified that, inside a sealed carton of Crescent Pharma Limited Ramipril 2.5mg capsules, two blister strips of Ramipril 10mg capsules were found by a healthcare professional. Both product batches were manufactured at the same site, and the error appears to have occurred during packaging of the cartons.
Ramipril is a medicine used for the treatment of hypertension (high blood pressure), kidney disease and heart failure.
Dr Alison Cave, MHRA Chief Safety Officer, said
“If you take Crescent Pharma Limited Ramipril 2.5mg capsules, check the packaging for batch number GR155023. The batch number and expiry date information can be found on the outer carton. If you have received this batch, check that the medication strength on the carton matches the blister strips inside.
“If the 2.5mg carton of Crescent Pharma Limited Ramipril contains blister strips that are labelled as Ramipril 10mg capsules, do not to take the medicine and contact your dispensing pharmacy. If the carton contains blister strips that are correctly labelled as Crescent Pharma Limited Ramipril 2.5mg capsules, you do not need to take further action and should continue to take your medicine as usual.
“If you have an affected pack or previously received this batch and you believe you have taken any Ramipril 10mg capsules that were included in error and are currently experiencing any side effects, please seek medical advice.
“Signs and symptoms may include feeling lightheaded, fainting or being fatigued, or altered kidney function and may be more serious for vulnerable patients. Any possible impact of taking a higher dose of ramipril should be assessed by a healthcare professional to determine whether any examination or tests are needed.
“If you have this batch of medicine, please take the leaflet that came with your medicine and any remaining tablets with you to your pharmacy or GP practice. Any suspected side effects should also be reported via the MHRA Yellow Card scheme.”
The MHRA has advised pharmacy and healthcare professionals to stop supplying the impacted batch and return all remaining stock to their suppliers.
Notes to editors
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Please see MHRA’s Class 2 recall for further information and images of the affected product.
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The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the [email protected], or call on 020 3080 7651.
