Notice on quality defect of the batch 3055005A of Cadil 25 mg tablets and the batch 4242001B of Excita 10 mg film-coated tablets
06.02.2015
Farmal d.d., the marketing authorisation holder for Cadil 25 mg tablets and Excita 10 mg film-coated tablets has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the discovered quality defect of the batch 3055005A of Cadil 25 mg and batch 4242001B of Excita 10 mg.
The discovered quality defect concerns a printing error on the outer packaging. Namely, on the packaging of these batches, except for information authorised in the marketing authorisation procedure, Batch No and Expiry date, the manufacturing date is printed by mistake in the space foreseen for the Expiry date of the medicine. Therefore, the information on the manufacturing date is printed in the space foreseen for the expiry date and the expiry date is printed in the raw below.
The concerned batches are placed on the Croatian market with an obligation to provide a written note on this quality defect to pharmacies.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
