Drug Safety Alerts

Hizentra Voluntary Withdrawal

1/10/2022

On January 10, 2022, CSL Behring issued an updated patient-level withdrawal of Hizentra® 20% (10 g/50 mL), NDC #44206-0455-10, to add two additional lots to its December 30, 2021 withdrawal. This withdrawal was issued due to an increased frequency of reports of injection-site reactions and local hypersensitivity-type of events after administration.

This withdrawal has been UPDATED to include the following lot numbers P100369102 exp. 02/16/2024 & P100369103 exp. 02/18/2024; P100343632 exp. 11/24/2023 previously withdrawn. No other lots are affected by this withdrawal.

CSL Behring has advised that at this time, the cause of the increase in injection-site reactions and hypersensitivity-type reactions is unknown, and that an investigation is ongoing. The reactions reported included itching, redness, swelling and welts 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.