Class 4 Medicines Notification: Lansoprazole Gastro-resistant Hard Capsules 15mg, EL(25)A/06

Source: MHRA/Gov.uk 11.2.25

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

Medicine Details

Lansoprazole Gastro-resistant Hard Capsules 15mg

PL: 10622/0308

Active ingredient: lansoprazole

SNOMED code: 9889911000001104

Manufactured By

Teva UK Limited

Affected Lot Batch Numbers

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.

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.

Recipients of this Medicines Notification 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

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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Class 4 Medicines Notification: Lansoprazole Gastro-resistant Hard Capsules 15mg, EL(25)A/06

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