Crescent Pharma Limited is recalling a batch of its 2.5mg ramipril capsules after some cartons were found, or may contain, blister strips of the higher 10mg strength. The Medicines and Healthcare products Regulatory Agency said the action followed two 10mg blister strips being discovered inside a sealed carton of the 2.5mg product by a healthcare professional.
The agency said the key risk is unintentional overdosing, with patients prescribed the lower dose potentially receiving 10mg capsules instead. Ramipril is used to treat high blood pressure, kidney disease and heart failure, so a mix-up in strength carries immediate safety concerns for people taking the medicine as directed.
What makes this recall more troubling is that it comes after earlier action on Crescent Pharma ramipril products on 20 April and 6 March. Those recalls covered the 10mg and 5mg strengths, and all three have been tied to packaging errors, suggesting the problem has affected more than one batch and more than one dose.
The MHRA said the error appears to have happened during packaging of the cartons, even though both product batches were manufactured at the same site. That detail points to a failure late in the process rather than a problem with the medicine itself, but the agency has not said how many cartons or patients are affected by the latest batch.
For pharmacists, the instruction is immediate: stop supplying the impacted ramipril 2.5mg batch, quarantine all remaining stock and return it to the supplier through approved processes. Olivier Picard said significant recalls can be costly and time-consuming for pharmacies, adding that one pharmacist spent eight hours quarantining stock during another ramipril recall. He said the repeated disruptions also make it harder to maintain patients’ trust in the medicines they are given.
Dr Alison Cave said any possible impact of taking a higher dose of ramipril should be assessed by a healthcare professional to determine whether examination or tests are needed. The MHRA said symptoms may include feeling lightheaded, fainting, fatigue or altered kidney function, and that the effects may be more serious for vulnerable patients. The recall is Crescent Pharma’s third product recall in three months, and the unresolved question is how far the packaging failures extend across its ramipril supply.
