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 reference number
MDR 113-05/24
Company name
Accord-UK Ltd
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 |
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.
Advice for 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.
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.
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
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