MHRA Class 3 Medicines Recall: Trandolapril 2mg and 4mg capsules (Viatris UK Healthcare Ltd)
MHRA Class 3 Medicines Recall: Trandolapril 2mg and 4mg capsules (Viatris UK Healthcare Ltd)
Drug alert number: EL(24)A/47
Date issued: 07 October 2024
The Medicines and Health products Regulatory Agency (MHRA) has issued a Class 3 medicines defect information notice for: Trandolapril 2mg and 4mg capsules (Viatris UK Healthcare Ltd)
Company name: Viatris UK Healthcare Ltd
Product name: 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 |
Product name: Trandolapril 4mg 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 |
Active Pharmaceutical Ingredient: trandolapril
Brief description of the 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 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 action is required by patients as this is a Pharmacy and Wholesaler level recall. 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 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).
