Baxter: Labeling Error on Sterile Water

Link to NHF’s Medical Advisory

November 16, 2011

Baxter Healthcare Corporation has sent a notice of a labeling error affecting the expiration date of the Sterile Water for Injection that is packaged as a diluent with RECOMBINATE [Antihemophilic Factor (Recombinant)]. The Sterile Water for Injection label indicates that the shelf life is longer than what was actually approved by the FDA.

Please continue to use the RECOMBINATE product as labeled on the kit. There is no impact to the safety or efficacy of Recombinate if the Sterile Water for Injection diluent is used before the expiration date of the RECOMBINATE.

The following are the NDC and Lot numbers of the Sterile Water for Injection vials:

If you have any questions, please call Stericycle, Inc. at 1-888-UPDATE-U.

PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia.

CHAPTERS: Please distribute this information to your membership.

Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The system is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge. To enroll in the PNS, please go online at http://www.patientnotificationsystem.org/ or else call (888) UPDATE-U.