Immune Globulin (GamaSTAN S/D) - Uncalibrated Syringes
March 6, 2008
Talecris and FDA informed healthcare professionals that one lot of GamaSTAN S/D (human immune globulin) was inadvertently distributed in uncalibrated 2 mL prefilled syringes with fixed needles. The lot number is 26N87P1, and it expires October 8, 2009.
The affected syringes lack any graduation marks. These syringes may not be used for administering doses less than 2 mL, administering a 2 mL dose using multiple sites, or when a needle with a different length or gauge is needed based on the patient’s size or the injection site. Instead, the syringe contents must be aseptically transferred to a sterile vial or sterile graduated syringe prior to administration. Instructions for these procedures are available from Talecris online at: http://www.fda.gov/downloads/BiologicsBloodVaccines/SafetyAvailability/UCM155640.pdf. The Talecris Help Line is also available 24 hours a day at 919-412-1030 for additional questions.
Additional information is available at the following link:
- CBER Safety Alert:
March 6, 2008; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.