As a precautionary measure, CSL Behring has instituted a Class II voluntary recall at the pharmacy level of certain batches of ZEMAIRA®, due to a manufacturing deviation that occurred during the filling process.
Patients can continue to use product they may have. Although the potential for safety risk to patients is considered low, it cannot be fully excluded.
Our commitment to patient care continues to be a key priority and guiding principle and our goal is to manage supply so that patients experience minimal disruption.
In this regard, we are pleased to be able to report that the distribution hold we had on inventoried product is now lifted and we expect to begin shipping ZEMAIRA in the coming days.
Patients are encouraged to contact their pharmacy regarding their individual prescription and to contact their physician about their treatment plan. If patients have medical questions regarding the select lots, they can call CSL Behring Medical Information at 1‐800‐504‐5434.
With our continued diligence to evaluate product impact, we have identified additional lots that are now included below highlighted in yellow.