MHRA Class 3 Medicines Recall: Trandolapril 0.5mg, 2mg, 4mg Capsules (Accord-UK Ltd)
Class 3 Medicines Recall: Trandolapril 0.5mg, 2mg, 4mg Capsules (Accord-UK Ltd)
Drug alert number: EL (24)A/35
MDR number: MDR 113-05/24
Date issued: 08 August 2024
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines recall for: Trandolapril 0.5mg, 2mg, 4mg Capsules (Accord-UK Ltd)
Company name: Accord-UK Ltd
Product name: Trandolapril 0.5mg Capsules, PL 0142/0937
SNOMED Code: 14406911000001102
| Batch Number | Expiry date | Pack size | First distributed |
| 909343 | 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 |
Product name:Trandolapril 2mg Capsules, PL 0142/0939
SNOMED Code: 14408411000001106
| Batch Number | 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 |
Product name: Trandolapril 4mg Capsules, PL 0142/0940
SNOMED Code: 14409011000001107
| Batch Number | 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 |
Active Pharmaceutical Ingredient: Trandolapril
Brief description of the 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 for healthcare professionals
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
View full alert here.
Advice for patients
No further 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.
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.
