The Alpha-1 Foundation has received the following correspondence from Grifols on March 26, 2021:
March 26, 2021
RE: Voluntary Withdrawal of Gamunex-C Lot No. A3GLE01462
As part of our ongoing commitment to patient safety and product quality, Grifols recently initiated a voluntary market withdrawal of one product lot of Gamunex-C (immune globulin injection [human], 10% caprylate/ chromatography purified) (lot number A3GLE01462). This voluntary withdrawal was undertaken due to a higher than expected rate of allergic/hypersensitivity type reactions associated with these specific product lots.
Although allergic reactions are a known possible adverse reaction with all immune globulin products, a small number of events associated with the withdrawn product lots were considered medically significant. A copy of the Withdrawal Notification is attached to this letter. Additional information about Gamunex-C and full prescribing information can be found at: www.gamunex-c.com.
After passing all FDA and Grifols internal safety and quality control tests, the product lots were released to the market. All Grifols’ distributors and direct customers who received products from these lots have been instructed to stop using the product, to notify any third parties to whom product vials may have been subsequently distributed, and to return any remaining inventory to Grifols. Upon learning of the higher than expected number of adverse events, Grifols initiated the voluntary withdrawal and posted it to the industry voluntary Patient Notification System (www.patientnotificationsystem.org).
At Grifols, we consider it an honor to provide patients and healthcare providers essential medicines that meet the highest standards of quality and safety. With a history that spans three generations and over 100 years, a commitment to improving the health and well-being of people around the world is central to our mission. If you have any questions regarding this voluntary withdrawal, please contact our Clinical Communications team at 800-520-2807. Other customer service inquiries should be directed to (800) 243-4153.
Pharmacovigilance reporting can be done through our website at https://www.grifols.com/en/web/international/pharmacovigilance.
We are grateful for the trust and confidence you place in the more than 24,000 Grifols employees who work each day to serve you.
Christopher Healey President