The Medicines and Healthcare products Regulatory Agency (MHRA) and Tesco Pharmacy have issued precautionary recalls for multiple batches of Ramipril capsules and Napralief tablets, citing manufacturing errors and incomplete patient information leaflets. The recalls involve a batch of Ramipril 10mg capsules where a blister pack of Ramipril 5mg was found inside a sealed carton, a separate batch of Ramipril 5mg capsules mistakenly packed with Amlodipine 5mg tablets, and three batches of Napralief 250mg tablets missing crucial safety and dosage instructions.
According to the MHRA, Crescent Pharma Limited is recalling one batch of Ramipril 10mg Capsules (Batch No.: GR174091) as a precautionary measure due to a potential error at the manufacturing site. The agency reported that one complaint had been received where a blister pack of Ramipril 5mg Capsules (Batch No.: GR164094) was found inside a sealed carton of Ramipril 10mg capsules. The recall is classified as a Class 2 Patient, Pharmacy and Wholesaler level recall, meaning the product may cause temporary or medically reversible adverse health consequences. Healthcare professionals have been instructed to immediately cease supplying the affected batch, quarantine remaining stock, and return it to the supplier. The MHRA advised patients who have received the impacted batch to check that the carton contains the correct medication, using the batch number and expiry date on the outer carton.
In a separate incident, Tesco Pharmacy issued a precautionary recall for a specific batch of Ramipril 5mg capsules (Batch No.: GR164099) that were mistakenly packed with Amlodipine 5mg tablets. The affected batch was distributed by Crescent Pharma Limited. Tesco Pharmacy urged customers who have bought the affected batch to stop taking them immediately. The pharmacy confirmed that no other Ramipril 5mg capsules or products are impacted by this recall. The batch numbers differ between the two Ramipril incidents: the blister pack found in the Ramipril 10mg carton was batch GR164094, while the Tesco recall involves batch GR164099, suggesting two separate manufacturing errors.
Both Ramipril and Amlodipine are used to treat high blood pressure, but taking Amlodipine instead of Ramipril may cause dizziness due to lower blood pressure, according to Tesco Pharmacy. However, the pharmacy stated that the risk to health from taking Amlodipine instead of Ramipril is very low. Tesco Pharmacy apologized for any inconvenience caused and advised patients to seek advice from their pharmacy or healthcare professional if they have questions. The pharmacy also reassured patients who have already taken Amlodipine that there is a very low risk to their health.
Separately, the MHRA announced that Omega Pharma Limited is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing safety and dosage information in the patient information leaflet and outer carton. Three batches are affected: B51496, B51497, and B51102. The affected cartons lack the instruction that patients must not take more than three tablets a day. 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).
Additionally, the Napralief leaflet is missing advice about eye examinations for visual disturbances, warnings about serious allergic reactions, and guidance to inform a doctor before blood or urine tests. Information about heart problems, autoimmune diseases, and serious skin reactions is also missing from the leaflet. Dr Alison Cave, MHRA Chief Safety Officer, stated that Napralief 250mg is considered safe when used in line with the correct dosage instructions. She noted that although small unintentional dosing mistakes are usually not harmful, complete and accurate safety information is essential to help ensure patients use their medicine correctly. Dr Cave provided correct 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, if needed, one tablet should be taken every 6-8 hours; and Napralief should not be taken for more than three days.
The number of patients affected by the Ramipril 10mg packaging error and the Ramipril 5mg/Amlodipine mix-up has not been disclosed. The total number of packs distributed for each affected batch remains unknown. It is also unclear whether any adverse events have been reported due to the Napralief missing information. The specific manufacturing site responsible for these errors has not been identified. Patients who have purchased any of the affected products are advised to contact their pharmacy or healthcare professional for further guidance.