A deviation was found during the dissolution test in the framework of the stability study
The EOF announced the recall of batches of the drug Cinacalcet/Pharmazac FCTab 30mg/tab for the treatment of thyroid gland diseases.
In particular, the EOF decided to recall batches 2201001A & 2201000A (expiry date 02.2025), of the medicinal product Cinacalcet/Pharmazac FCTab 30mg/tab, as a discrepancy was found during the dissolution test in the context of a stability study.
The company PHARMAZAK AFEVE, as Marketing Authorization Holder, must immediately contact the recipients of the specific batches and withdraw them from the market within a reasonable period of time.
The relevant documents are kept for a period of at least five (5) years and are brought to the attention of the EOF, if requested.
