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.
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