LONDON, May 28 -- The government of the United Kingdom issued the following news:
Crescent Pharma Limited is recalling one batch of Ramipril 2.5mg capsules as a precautionary measure due to apackaging error which may mean some cartons contain blister strips of a higher dose, specifically Ramipril 10mg.
This follows acomplaintwhich identified that, inside a sealed carton of Crescent Pharma Limited Ramipril 2.5mg capsules, twoblisterstripsof Ramipril10mg capsules were found by a healthcareprofessional.Both product batches were manufactured at the samesite, and the error appears to have occurred during packaging of the cartons.
Ramipril isamedicine usedforthe treatment of hypertension(high blood pressure), kidneydiseaseand heart failure.
Dr Alison Cave, MHRA Chief Safety Officer, said:
"If you take Crescent Pharma LimitedRamipril 2.5mgcapsules, 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 strengthon the carton matches the blister strips inside.
"If the 2.5mg carton ofCrescent Pharma LimitedRamipril contains blister strips that are labelled as Ramipril 10mg capsules, do not to take the medicine andcontactyour 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 andshouldcontinue totake your medicineas usual.
"If you have anaffectedpack 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 sideeffects, please seek medical advice.
"Signs and symptoms may include feeling lightheaded,faintingor being fatigued,or altered kidney function and may be more serious for vulnerable patients.Anypossible impactof taking a higher dose of ramipril should be assessed by a healthcare professional todeterminewhether any examination or tests are needed.
"If youhavethisbatch ofmedicine,pleasetake the leaflet that came with your medicine and any remaining tablets with you to your pharmacy or GP practice. Any suspectedside effectsshould also be reported via the MHRA Yellow Card scheme."
TheMHRA has advisedpharmacy and healthcare professionals to stop supplying the impacted batchand returnall remaining stock to their suppliers.
Notes to editors
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Please seeMHRA's Class2recall forfurther 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 contactthe newscentre@mhra.gov.uk, or call on 020 3080 7651.
Disclaimer: Curated by HT Syndication.
