Information on recall of one batch of Lizinopril Farmal 10 mg tablets (lisinopril)
22.05.2014
Farmal d.d., the marketing authorisation holder for lisinopril Farmal 10 mg tablets (lisinopril) has informed the Agency for Medicinal Products and Medical Devices (HALMED) on recall of one batch of this medicine from the Croatian market. The batch 130501, shelf life : 05, 2016 is being recalled due to quality defects.
There are other batches of Lizinopril Farmal 10 mg tablets available on the Croatian market that are not affected by this quality defect. Therefore, the recall of this batch is not expected to cause shortage of Lizinopril Farmal 10 mg tablets and patients treated with this medicine should continue their therapy.
HALMED has so far not received any suspected quality defect of Lizinopril 10 mg tablets. HALMED will continue monitoring the use of this medicine and will inform the public promptly about any new information.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. 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 with their doctor or pharmacist about the continuation of their therapy.
