Drug Safety Alerts

Hizentra® 20% (10 g/50 mL) Patient-Level Recall

4/13/2021

On April 13, 2021 CSL Behring issued a patient-level recall of Hizentra® 20% (10 g/50 mL) NDC #44206-0455-10. This recall was issued due to an increased frequency of reports of injection-site reactions after administration.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

This recall affects lot P100287881 exp. 05/25/2023. No other lots are affected by this recall. The affected lot went into distribution beginning in February 2021.

CSL Behring has advised that at this time, the cause of the increase in injection-site reactions is unknown, and that an investigation is ongoing. The reactions reported included itching, redness and swelling around the injection site, all commonly reported reactions to Hizentra®. CSL Behring has advised that based on this, the potential safety risk to patients is considered low.

CVS Caremark Response: CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Hizentra® 20% (10 g/50 mL) to contact their prescriber.

For more information, please contact CSL Behring Medical Information at 1-800-504-5434 or e-mail MedInfoNA@cslbehring.com. You may also call the U.S. Food and Drug Administration at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their Web site at www.fda.gov.