FAQs - Fresenius Kabi USA, LLC UFH Products
Will Fresenius Kabi USA, LLC Unfractionated Heparin (UFH) be compliant with the new USP standard required for October 1, 2009?
Yes. Fresenius Kabi USA, LLC was on time in implementing new heparin raw material purity standards that were required by the USP in 2008 (stage 1). In addition, Fresenius Kabi USA, LLC UFH products shall be in compliance with the new USP changes required for October 1, 2009 (stage 2), which include harmonization with the International Standard among other changes (see above).
How can one distinguish between vials of Fresenius Kabi USA, LLC UFH prepared with the previous USP standard and vials of UFH prepared with the new USP standard?
Fresenius Kabi USA, LLC's vials of UFH prepared with the new USP standard will be marked with the letter "N" (for "new") after the expiration date on every vial.
What is the shelf life of Fresenius Kabi USA, LLC UFH products, and how long will there be product of both types on the market?
The shelf lives of Fresenius Kabi USA, LLC Heparin Sodium Injection, USP and Heparin Lock Flush Solution, USP products range from 24 to 36 months. Fresenius Kabi USA, LLC expects to begin shipping product in compliance with the new USP standard by the end of October.
Inventory levels vary by code at the individual wholesaler distribution center. In order for customers to clearly differentiate product tested using the new USP standards, APP will be incorporating an "N" (for "new") after the expiration date on every vial. It is possible that once Fresenius Kabi USA, LLC begins shipping, product meeting the two different standards will be in circulation together for up to three years.
Should we return Fresenius Kabi USA, LLC UFH product manufactured using the previous USP standard and exchange it for Fresenius Kabi USA, LLC UFH product manufactured using the new USP standard?
No. Fresenius Kabi USA, LLC has tested all of its heparin raw material dating back to 2006 (which was used for finished UFH within expiry in circulation) and all Fresenius Kabi USA, LLC heparin was found to be contaminant free.
When does Fresenius Kabi USA, LLC expect to ship the new stage 2 product lots? When will the new vial be available and should pharmacists stock up on the current vials to bridge through that time?
Lots manufactured under the Stage 2 USP Monograph are expected to be released and shipped as early as the end of October. Institutions may purchase additional Stage 1 product, providing additional time to manage the transition. Inventory levels vary by code at the individual wholesaler distribution center. In order for customers to clearly differentiate product tested using the new USP standards, Fresenius Kabi USA, LLC will be incorporating an "N" (for "new") after the expiration date on every vial.
Will the Stage-2 product be available in all sizes?
This USP Stage-2 monograph change will be made to all current Fresenius Kabi USA, LLC Heparin Sodium Injection and Heparin Lock Flush product codes.
How can I obtain more information about this change?
Fresenius Kabi USA, LLC has the following resources available for further information:
Fresenius Kabi USA, LLC Website: http://www.apppharma.com
Fresenius Kabi USA, LLC Customer Service at 888-386-1300 between 7 a.m. and 6 p.m. (CST)
For clinical and technical questions call Fresenius Kabi USA, LLC Medical Information and Safety at 800-551-7176 between 8 a.m. and 5 p.m. (CST), or send an e-mail to This email address is being protected from spambots. You need JavaScript enabled to view it.
USP: http://www.usp.org/hottopics/heparin.html
FDA Drug Safety Information for Patients and Providers:
http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ ucm184502.htm
FDA Consumer Inquiries: 888-INFO-FDA
Print this page