As part of HFA鈥檚 ongoing mission to assist and advocate for the bleeding disorders community, this action alert is being issued to keep you informed about blood safety.
About This Withdrawal
Due to increased reports of hypersensitivity reactions such as rashes or urticaria and/or wheezing, Octapharma聽USA聽Inc. has voluntarily withdrawn from the market one lot of IVIG medication Octagam 5% [Immune Globulin Intravenous (human)] Liquid Prep therapy.
Who does this withdrawal impact?
This voluntary withdrawal impacts patients currently using聽Octagam 5% [Immune Globulin Intravenous (human)] Liquid Prep therapy treatment.
Steps Those Impacted Should Take:聽
1.聽聽聽聽Check all Octagam 5% labels for聽Lot K551A44.
2.聽聽聽聽Do not infuse聽with product from this lot.
3.聽聽聽聽Return affected product to the point of purchase to receive replacement product.
Where This Alert Came From
This post is not intended to make any medical claim. This withdrawal announcement was聽issued by Octapharma USA, Inc., and an聽alert聽was sent聽by Stericycle, Inc., managers of the聽Patient Notification System (PNS).
The聽PNS聽alerts registrants聽within 24 hours of a product聽recall or withdrawal.聽All manufacturers聽that currently have clotting factor products on the market are participating in this vital notification system reaching registered community members, physicians, nurses, and pharmacies.
This system is聽fast, free,聽and聽confidential.
About the Patient Notification System
Currently, fewer than 8,000聽patients are enrolled in the PNS system (that’s less than 40% of the bleeding disorders community)! 聽Are you signed up?
The聽PNS聽is designed to alert patients within 24 hours of recalls that include:
- Defective sterile water vials
- Improperly packaged alcohol wipes
- Problems with the product potency and shelf life
- Mislabeled products
- Factor contamination
- And many more
If you have medical questions regarding this withdrawal, contact your physician. For clinical questions about Octagam 5%, contact Dipen Patel, Head of US Drug Safety Unit at (202) 604-1137.
For assistance regarding this recall, please call Stericycle, Inc., manager of the Patient Notification System, at 1-888-UPDATE-U (888-873-2838).