Class 3 Medicines Recall: Viatris UK Healthcare Ltd, Trandolapril 2mg and 4mg capsules, EL(24)A/47
Generics (UK) Ltd T/A Mylan UK is recalling specific batches of trandolapril after re-testing showed out of specification results.
DMRC/MDR Number: DMRC 31208200
Company name: Viatris UK Healthcare Ltd
Product descriptions:
Trandolapril 2mg capsules PL 04569/0819 SNOMED Code 13694511000001100
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1208031 | Jun-25 | 28 | 22-Feb-23 |
| 1210889 | Sep-25 | 28 | 28-Jun-23 |
| 1210890 | Oct-25 | 28 | 14-Jul-23 |
| 1305267 | Apr-26 | 28 | 11-Sep-23 |
| 1309346 | Sep-26 | 28 | 02-Apr-24 |
| 1309514 | Sep-26 | 28 | 20-May-2024 |
Trandolapril 4 mg capsules PL 04569/0820 SNOMED Code 13694911000001107
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1210643 | Oct-25 | 28 | 30-May-23 |
| 1305411 | Feb-26 | 28 | 10-Sep-23 |
| 1305413 | Apr-26 | 28 | 17-Dec-23 |
| 1308126 | Apr-26 | 28 | 04-Mar-24 |
| 1309520 | Sep-26 | 28 | 20-Mar-24 |
Brief description of problem:
Generics (UK) Ltd T/A Mylan UK is recalling specific batches of trandolapril after re-testing showed out of specification results. The listed batches are being recalled as a precautionary measure after testing showed variability of the Trandolapril content. Note: the problem is limited to the batches listed in this notification.
Advice to Healthcare Professionals:
Stop supplying the above batches 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 Viatris UK Healthcare Limited Medical Information at +44 (0)1707 853 000 (select option 1) or info.uk@viatris.com.
For stock control enquiries please contact Customer Services at +44 (0)1707 853 000 (select option 2).
To access the full recall: Class 3 Medicines Recall: Viatris UK Healthcare Ltd, Trandolapril 2mg and 4mg capsules, EL(24)A/47