The European Haemophilia Consortium (EHC) was informed of a voluntary recall of a series of batches of human coagulation factor IX, known under the brand name of “Mononine,” and manufactured by CSL Behring.

This voluntary recall is a precautionary measure due to a manufacturing deviation (i.e., a change) during the filling process. Following extensive testing and analysis of pharmacovigilance data, the manufacturer concluded that the safety risk is low but existent. Patients in possession of product from the batches listed below should get in touch with their pharmacist and clinician to further discuss their treatment and, eventually, seek alternative therapeutic options.

Questions regarding this recall can be addressed directly to the manufacturer via their local branches found on the CSL Behring website.

 

Recalled lots of Mononine® 1000 IU
Batches Expiration
P100117832
4/30/2021
P100157497
4/30/2021
P100157506
4/30/2021
P100198086
4/30/2021
P100157486
7/31/2021
P100157493
7/31/2021
P100221185
7/31/2021