As part of HFA’s 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of hypersensitivity reactions such as rashes or urticaria and/or wheezing, OctapharmaÂ USAÂ Inc. has voluntarily withdrawn from the market one lot of IVIG medication Octagam 5% [Immune Globulin Intravenous (human)] Liquid Prep therapy.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 usingÂ Octagam 5% [Immune Globulin Intravenous (human)] Liquid Prep therapy treatment.
Steps Those Impacted Should Take:Â
1.Â Â Â Â Check all Octagam 5% labels forÂ Lot K551A44.
2.Â Â Â Â Do not infuseÂ with product from this lot.
3.Â Â Â Â 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 wasÂ issued by Octapharma USA, Inc., and anÂ alertÂ was sentÂ by Stericycle, Inc., managers of theÂ Patient Notification System (PNS).
TheÂ PNSÂ alerts registrantsÂ within 24 hours of a productÂ recall or withdrawal.Â All manufacturersÂ 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 isÂ fast, free,Â andÂ confidential.
About the Patient Notification System
Currently, fewer than 8,000Â patients are enrolled in the PNS system (that’s less than 40% of the bleeding disorders community)! Â Are you signed up?
TheÂ PNSÂ 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).