January 21, 2021- We have become aware today of this voluntary Class II recall from CSL Behring. Please see full statement below issued from CSL Behring for additional information. A Class II recall by FDA definition is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Click here for link to FDA website.
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 always manage supply so that patients experience minimal disruption.
Patients are encouraged to contact their pharmacy regarding their individual prescription and to contact their physician about their treatment plan and potential alternative therapy options. If patients have medical questions regarding the select lots, they can call CSL Behring Medical Information at 1‐800‐504‐5434.
We recognize the concern this presents for patients, physicians and pharmacists, and will keep the community apprised of the situation.