In the recall of a well-known anticoagulant medication, The National Organization for Medicines (EOF) took action.
According to the organization, This is the medication Clodelib F.C. 75 mg/tablet BTX30 (PVC/PE/PVDC/aluminum foil blister packs, 30 x 10, with an expiration date of 02/2023).
The batch being recalled is 1102618; the Agency explains that it is taking this action because the results of the quantitative analysis do not comply with the product specifications.
According to the National Organization for Medicines (EOF), «LIBYTEC PHARMACEUTICALS S.A., as the holder of the marketing authorization for the product in Greece, is required to contact its customers immediately to withdraw the product from the market.».
The announcement in detail:
«The recall of lot 1102618 of the pharmaceutical product CLODELIB F.C.TAB 75MG/TAB BTX30 (PVC/PE/PVDC/aluminum foil blisters, 30×10, with an expiration date of 02/2023) because the results of the quantitative analysis do not comply with the product specifications.
This decision is issued with the aim of supporting the company’s voluntary recall in the interest of protecting public health.
LIBYTEC PHARMACEUTICALS S.A., as the holder of the marketing authorization for the product in Greece, is required to contact its customers immediately so that they can withdraw the product from the market.
»Recall records must be retained for a period of at least five (5) years and made available to the National Organization for Medicines (EOF) upon request.".
The relevant decision HERE
