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.

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