MHRA Class 4 Medicines Notification: Lansoprazole Gastro-resistant Hard Capsules 15mg (Teva UK Limited)
MHRA Class 4 Medicines Notification: Lansoprazole Gastro-resistant Hard Capsules 15mg (Teva UK Limited)
Drug alert number: EL(25)A/06
Date issued: 11 February 2025
Teva UK Limited is reporting a minor typographical error on the carton for Lansoprazole Gastro-Resistant Hard Capsules 15mg. There are two instances where the dosage form is stated as “tablets” where it should state “gastro-resistant capsule, hard”.
DMRC reference number:DMRC-34494415
Company name: Teva UK Limited
Product name: Lansoprazole Gastro-resistant Hard Capsules 15mg PL 19156/0089
SNOMED Code: 9889911000001104
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 20429 | 31/03/2026 | 28 | 12/07/2024 |
| 20621 | 31/03/2026 | 28 | 16/07/2024 |
| 20622 | 31/03/2026 | 28 | 11/07/2024 |
| 21023 | 31/03/2026 | 28 | 12/07/2024 |
| 21435 | 31/03/2026 | 28 | 12/07/2024 |
| 21568 | 30/04/2026 | 28 | 09/10/2024 |
| 22625 | 31/05/2026 | 28 | 07/11/2024 |
| 22629 | 30/06/2026 | 28 | 11/12/2024 |
| 22717 | 30/06/2026 | 28 | 17/09/2024 |
| 23307 | 30/06/2026 | 28 | 12/11/2024 |
| 25390 | 31/07/2026 | 28 | 24/12/2024 |
| 25541 | 30/09/2026 | 28 | 21/01/2025 |
Active Pharmaceutical Ingredient: lansoprazole
Background
Teva UK Limited is reporting a minor typographical error on the carton for Lansoprazole Gastro-Resistant Hard Capsules 15mg. There are two instances where the dosage form is stated as “tablets” where it should state “gastro-resistant capsule, hard” – these are shown circled in red on the diagram below:
Advice for healthcare professionals
There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to reassure patients, if contacted, that the cartons only contain capsules as prescribed and that this is a typographical error.
View full alert here
Advice for patients
Patients should continue to take capsules from these batches as prescribed by your healthcare professional. This does not affect the quality of the medicine. The cartons contain capsules as prescribed and this is a printing error. If you have concerns about a medicine you may be using, please contact 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.
Alternatively, you can report by calling 0800 731 6789 for free, Monday to Friday between 9am and 5pm.
Additional information:
For medical information enquiries please telephone 0207 540 7117 or email medinfo@tevauk.com.
For stock control enquiries telephone 0800 590502 or email Customer.services@tevauk.com.
