Class 3 Medicines Recall: Accord-UK Ltd, Trandolapril 0.5mg, 2mg, 4mg Capsules, EL(24)A/35
Accord-UK Ltd is recalling the listed batches after retesting showed out of specification results.
MDR Number: MDR 113-05/24
Company name: Accord-UK Ltd
Product descriptions:
Trandolapril 0.5mg Capsules, PL 0142/0937 SNOMED Code 14406911000001102
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1909343 | Aug-24 | 14 | 24-Dec-2019 |
| 1003165 | Feb-25 | 14 | 19-May-2020 |
| 1003848 | Feb-25 | 14 | 04-Jun-2020 |
| 1009756 | Apr-25 | 14 | 10-Nov-2020 |
| 1009755 | Jun-25 | 14 | 13-Nov-2020 |
| 1101732 | Aug-25 | 14 | 15-Jun-2021 |
Trandolapril 2mg Capsules, PL 0142/0939 SNOMED Code 14408411000001106
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1105358 | Mar-26 | 28 | 13-Jul-2021 |
| 1203753 | Feb-27 | 28 | 28-Jun-2022 |
| 1203754 | Apr-27 | 28 | 12-Jul-2022 |
| 1206236 | Jun-27 | 28 | 13-Sep-2022 |
| 1206237 | Jun-27 | 28 | 28-Nov-2022 |
| 1210785 | Oct-27 | 28 | 08-Mar-2023 |
| 1300480 | Dec-27 | 28 | 18-Apr-2023 |
| 1301041 | Dec-27 | 28 | 30-May-2023 |
| 1305174 | Apr-28 | 28 | 20-Oct-2023 |
| 1401190 | Dec-28 | 28 | 07-Jun-2024 |
Trandolapril 4mg Capsules, PL 0142/0940 SNOMED Code 14409011000001107
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1008652 | Aug-25 | 28 | 21-Oct-2020 |
| 1010286 | Aug-25 | 28 | 19-Jan-2021 |
| 1105356 | Mar-26 | 28 | 22-Jun-2021 |
| 1202967 | Mar-27 | 28 | 18-Jul-2022 |
| 1207436 | Jun-27 | 28 | 02-Mar-2023 |
| 1401189 | Dec-28 | 28 | 31-May-2024 |
Brief description of problem:
Accord-UK Ltd is recalling the above batches after retesting showed out of specification results. The listed batches are being recalled as a precautionary measure after testing showed variability of the Trandolapril content beyond permitted levels. Note: the problem is limited to the batches listed in this notification.
Advice to Healthcare Professionals:
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Advice to Patients:
No action is required by patients as this recall is being undertaken at a Pharmacy and Wholesaler level as a precautionary measure. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.
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.
Company contacts for further information:
For medical information enquiries please contact Accord-UK Ltd Medical Information Department on 01271 385257
For stock control enquiries please contact Accord- UK Ltd Customer Services Team on 0800 373573.
To access the full recall: Class 3 Medicines Recall: Accord-UK Ltd, Trandolapril 0.5mg, 2mg, 4mg Capsules, EL(24)A/35