The Alpha-1 Foundation was informed by CSL Behring that a Voluntary Biological Product Recall is being initiated for 4 lots of Zemaira®, their prescription drug for augmentation therapy for the treatment of Alpha-1 Antitrypsin Deficiency (Alpha-1).
According to CSL Behring, these lots are being voluntarily recalled as a precautionary measure due to a manufacturing deviation.
Vials from the following Zemaira® lots were distributed from beginning August 2018 through October 2018: Y412608, Y412708, Y413008, Y413409.
Only the four mentioned lots are subject to CSL Behring’s voluntary recall; all other lots currently available for use are unaffected and may continue to be used.
CSL Behring expressed that, as agreed with the U.S. Food and Drug Administration (FDA), this recall is at the pharmacy level, which should immediately quarantine inventory of the affected product and contact their supplier to arrange for the return of the identified product.
Patients who have unused vials from these lots should return them to the pharmacy.
Patients will receive recall information if they have enrolled in the Patient Notification System (PNS).
“We have reached out to the FDA and the Plasma Protein Therapeutics Association (PPTA) for additional information,” said Miriam O’Day, president and CEO of the Alpha-1 Foundation. “Any information we obtain will be shared with the Alpha-1 community,” she added.
CSL Behring confirmed that there has been no increase in adverse experiences reported to them from patients receiving these lots, and that they expect no shipment delays – nor shortages, in the near future.
However, patients who have experienced adverse events with these lots and who have not reported them, should send an email to MedinfoNA@cslbehring.com.