Crescent Pharma recalls Ramipril 10mg capsules because some cartons may hold Ramipril 5 mg blister strips

Official notice

The notice's own wording from MHRA.

Class 2 Medicines Recall: Crescent Pharma Limited, Ramipril 10mg capsules, EL(26)A/19

DMRC reference number

DMRC- 39191133

Marketing Authorisation Holder

Crescent Pharma Limited

Medicine Details

Ramipril 10 mg Capsules PL: 20416/0297 Active ingredient: ramipril SNOMED code: 38577011000001100 GTIN: 05017123078132

Affected Lot Batch Numbers

Batch No. | Expiry Date | Pack Size | First Distributed GR174091 | 10/2026 | 28 | 13 May 2025

Background

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. Both product batches were manufactured at the same manufacturing site, and the error appears to have occurred during secondary packaging of the cartons of Batch GR174091. Please note this is a Class 2 Patient, Pharmacy and Wholesaler level recall.

Advice for Healthcare Professionals:

Stop supplying the impacted batch of Ramipril 10mg Capsules (Batch No GR174091) immediately. Quarantine all remaining stock and return it to your supplier using your approved process. 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. If batch/product traceability information is not available, pharmacists should identify all patients dispensed this product between 13 May 2025 and 16 April 2026. Where appropriate and feasible, contact all patients who have dispensed the impacted product with priority given to those who have been dispensed the product most recently and within the last 28 days. The majority of this was distributed in 2025 and therefore it is expected that many of these packs will have been dispensed to patients and consumed.

Advice for Healthcare Professionals to Provide to Patients:

Some cartons of Ramipril 10mg Capsules, manufactured by Crescent Pharma Limited, may contain blister strips of Ramipril 5 mg Capsule. All packs from the impacted batch of Ramipril 10 mg Capsule, (Batch Number GR174091) are being recalled as a precautionary measure. 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. - If the carton contains blister strips that are labelled and contain Ramipril 5 mg capsule, contact your dispensing pharmacy in the first instance. If the carton contains blister strips that are labelled and contain Ramipril 10 mg Capsules, you do not need to take further action. - If you are unsure or have any questions, please seek advice from your pharmacy or other healthcare professionals responsible for your care. Please take the leaflet that came with your medicine and any remaining capsules with you to your pharmacy or GP practice. Both strengths are used to treat high blood pressure, heart failure and kidney disease. Any possible impact of a lower dose of ramipril is expected to be gradual rather than immediate or life threatening. For reference, the description of the products are as follows: Ramipril 10 mg Capsules: Capsules are light grey and dark green capsules, marked with “R” on the cap and “10” on the body. Ramipril 5mg Capsule: Capsules are light grey and green gelatin capsules, marked with “R” on the cap and “5” on the body. See below for images showing the different medicines and where to find the batch number of the product and the identification of the incorrect blister strip. Ramipril 10 mg Capsules – Batch GR174091 Outer carton and BN/Exp Date information Ramipril 5mg Capsule – Batch GR164094 Representing images of incorrect blister strip Representing images of incorrect Capsule in 10mg pack Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Additional information:

For all medical information enquiries and information, please email medinfo@crescentpharma.com , for reporting of side effects email safety@crescentpharma.com or telephone +44 1217901596 and for stock control enquiries please email complaints@crescentpharma.com Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information. Yours faithfully Defective Medicines Report Centre 10 South Colonnade Canary Wharf London E14 4PU Telephone +44 (0)20 3080 6574 DMRC@mhra.gov.uk

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Class 2 Medicines Recall: Crescent Pharma Limited, Ramipril 10mg capsules, EL(26)A/19