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 Number
DMRC 31208200
Company name
Viatris UK Healthcare Ltd
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 |
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 batches 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 Viatris UK Healthcare Limited Medical Information at +44 (0)1707 853 000 (select option 1) or [email protected].
For stock control enquiries please contact Customer Services at +44 (0)1707 853 000 (select option 2).
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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