Advisory: Voluntary Recall of Mononine Batch

CSL Behring has issued a Class II recall of a batch of MONONINE® Coagulation Factor IX (Human). The recall is at the pharmacy level. According to the company statement, the recall is a precautionary measure due to a manufacturing deviation that occurred during the filling process. The statement says that “although the potential for safety risk to patients is considered low, it cannot be fully excluded.”

Here is a PDF where you can find the full company statement, including affected lot numbers.

If you have affected product, please contact your specialty pharmacy. As you may remember, this product was already being phased out by the manufacturer. However, there are a variety of potential alternatives, including plasma-derived, recombinant and longer-lasting products. If you are currently using MONONINE, please discuss options with your treatment center physician.