Recall of medicinal product batches following a case of the classic form of Creutzfeldt-Jakob Disease (sporadic CJD) in a French blood donor - Published on 06/12/2009
LFB Company Position
At the request of the French Health Products Safety Agency (Afssaps), LFB Biomedicaments is in the process of recalling batches of medicinal products present in hospital pharmacies in response to a probable case of sporadic Creutzfeldt-Jakob Disease in a blood donor whose plasma was used for manufacture of the batches concerned.
This recall is a precautionary measure. Based on current knowledge and in light of extensive epidemiological data, product safety is not jeopardized. To date, there is no evidence of a risk of contracting the classic form of Creutzfeldt-Jakob Disease from blood or its derivatives.
According to recommendations from the EMEA (European Agency) and the FDA (US Agency), only cases of the variant form of Creutzfeldt-Jakob Disease require a recall measure.
France is currently one of the rare countries in the world to recall plasma-derived medicinal products as a precautionary measure following a case of classic Creutzfeldt-Jakob Disease.
This batch recall will not cause a shortage of supply among LFB’s hospital clients.
Please contact LFB for further information
+33 (0) 1 69 82 72 80
Dr. Patrick Bergeat
+33 (0) 1 69 82 70 56