Drug Safety Alerts

Hizentra EXP2 Voluntary Withdrawal

12/30/2021

On December 30, 2021, CSL Behring issued a patient-level withdrawal of one lot of Hizentra® 20% (10 g/50 mL) NDC #44206-0455-10. 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 affects lot number P100343632 exp. 11/24/2023. 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.