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

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 Number: DMRC-34494415

Company name: Teva UK Limited

Product description: Lansoprazole Gastro-resistant Hard Capsules 15mg PL: 10622/0308 SNOMED code: 9889911000001104

Details of the affected batches: 

Brief description of problem: 

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 in the full recall.

Advice to 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 to 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.

Company contacts for further 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.

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