The MHRA has instructed healthcare professionals to immediately cease supplying the affected batch of Ramipril 10mg capsules and quarantine all remaining stock, according to the agency. The recall is a Class 2 Patient, Pharmacy and Wholesaler level recall, the MHRA said.
Crescent Pharma Limited is recalling one batch of Ramipril 10mg Capsules as a precautionary measure, the MHRA reported. The recall follows a manufacturing error where a blister pack of Ramipril 5mg capsules was found inside a sealed carton of the 10mg product, the agency said. The MHRA stated: "Crescent Pharma Limited has received one complaint to date, where it has been identified that, inside a sealed carton of Ramipril 10 mg Capsules Batch No.: GR174091, one blister pack of Ramipril 5 mg Capsules Batch No.: GR164094 was found." The agency urged patients who have received the impacted batch to check that the carton contains the correct medication.
Crescent Pharma Limited is recalling one batch of Ramipril 10mg Capsules as a precautionary measure due to a potential error at the manufacturing site. Crescent Pharma Limited has received one complaint to date, where it has been identified that, inside a sealed carton of Ramipril 10 mg Capsules Batch No.: GR174091, one blister pack of Ramipril 5 mg Capsules Batch No.: GR164094 was found.
Separately, Omega Pharma Limited is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing safety and dosage information from the patient information leaflet and outer carton, the MHRA said. Three batches are affected: B51496, B51497, and B51102, according to the agency. The affected cartons do not include the instruction that patients must not take more than three tablets a day, the MHRA reported. The patient information leaflet is missing dosage instructions for the first day (two tablets, then one tablet 6-8 hours later) and subsequent days (one tablet every 6-8 hours), the agency said. It also lacks advice about eye examinations, serious allergic reactions, and guidance to inform a doctor before blood or urine tests, the MHRA added. Dr Alison Cave, MHRA Chief Safety Officer, said: "Napralief 250mg is considered safe when used in line with the correct dosage instructions. Although small unintentional dosing mistakes are usually not harmful, complete and accurate safety information is essential to help ensure patients use their medicine correctly." She advised patients to continue using the medicine safely in line with the correct instructions.
Tesco Pharmacy has issued a precautionary product recall for a specific batch of Ramipril 5mg capsules that was mistakenly packed with Amlodipine 5mg tablets, the pharmacy said. The affected batch is GR164099, Tesco Pharmacy confirmed. No other Ramipril 5mg capsules or products are impacted by the recall, the pharmacy stated. Patients who have bought the affected batch are urged to stop taking them immediately, Tesco Pharmacy said. The pharmacy apologised for any inconvenience and noted that both medications are used to treat high blood pressure, but taking amlodipine instead of ramipril may cause dizziness due to lower blood pressure. It added that there is a very low risk to health if patients have already taken amlodipine.
If batch/product traceability information is available, pharmacy professionals and other healthcare professionals involved in dispensing medicinal products should identify and immediately contact all patients who have been dispensed the impacted product and ask them to confirm if they have remaining stock within their possession for return.
The number of patients affected by each recall has not been disclosed, and it is unclear which manufacturing site is responsible for the errors. No adverse events linked to these medication errors have been reported.
If you were prescribed Ramipril 10 mg Capsules and have received the impacted product batch (Batch Number GR174091) please check that the carton contains the correct medication. The batch number and expiry date information can be found on outer carton.
Napralief 250mg is considered safe when used in line with the correct dosage instructions. Although small unintentional dosing mistakes are usually not harmful, complete and accurate safety information is essential to help ensure patients use their medicine correctly.
Patients can continue to use the medicine safely in line with the correct safety and dosage instructions. Patients should take two tablets on the first day, followed by one tablet 6-8 hours later. For the second and third day of treatment, if needed, one tablet should be taken every 6–8 hours. Napralief should not be taken for more than three days.