The EOF proceeded with the recall of five batches of medicine for the treatment of thyroid gland diseases
The EOF proceeded with the recall of five batches of medicine for the treatment of thyroid gland diseases.
According to the EOF, it is the drug ‘Cinacalcet/Pharmazac’ FCTab 30mg/tab’, used for thyroid.
“We decide on it recall of lots 2201001A and 2201000A (expiration date 02.2025), of the pharmaceutical product ‘Cinacalcet/Pharmazac FCTab 30mg/tab’, as a deviation was found during the dissolution test in the context of a stability study.
The company PHARMAZAK AFEVE, as the marketing license 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 5 years and are brought to the attention of the EOF, if requested”.
In its next announcement about the same preparation, the EOF states the following:
“We decide to recall lots 2200931B, 2200999C and 2201004A (expiration date 02.2025), of the pharmaceutical product ‘Cinacalcet/FARAN FCTab 30mg/tab’, as a deviation was found during the dissolution test in the context of a stability study.
This Decision is issued with the aim of strengthening the preventive voluntary recall of the company FARAN ABEE, which, as Marketing Authorization Holder, must immediately contact the recipients of the specific lots and withdraw them from the market within a reasonable period of time.
The relevant documents are kept for a period of at least 5 years and are brought to the attention of the EOF, if requested”.
Source :Skai
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