IMPORTANT PRODUCT INFORMATION
Initiated by :  Baxter Bioscience now Baxalta US Inc. Event Id :  156 Event Date :  10-11-2013

Therapy	Gammagard Liquid [Immune Globulin Intravenous (Human)] 10% NDC Number Lot Number Size Packaging Expiration Date 0944-2700-02 LE12M035AC 1g - 02-13-2015 0944-2700-02 LE12M035AP 1g - 02-13-2015 0944-2700-02 LE12M043AC 1g - 02-22-2015 0944-2700-02 LE12M208AB 1g - 08-30-2015 0944-2700-02 LE12M227AC 1g - 09-10-2015 0944-2700-02 LE12M229AB 1g - 09-11-2015 0944-2700-02 LE12M254AB 1g - 10-02-2015 0944-2700-02 LE12M265AB 1g - 10-10-2015 0944-2700-02 LE12M303AB 1g - 11-22-2015 0944-2700-02 LE12N008AB 1g - 01-21-2016 0944-2700-02 LE12N032AB 1g - 02-09-2016 0944-2700-02 LE12N036AB 1g - 02-26-2016 0944-2700-02 LE12N063AB 1g - 03-23-2016 0944-2700-02 LE12N071AB 1g - 04-02-2016 0944-2700-02 LE12N098AB 1g - 04-22-2016 0944-2700-02 LE12N132AB 1g - 05-27-2016 0944-2700-02 LE12NC28AB 1g - 05-21-2016 0944-2700-02 LE12N175AB 1g - 07-02-2016 0944-2700-02 LE12M315AB 1g - 12-05-2016
Reason	Baxter Healthcare Corporation would like to notify you of a labeling error affecting certain lots of GAMMAGARD LIQUID [Immune Globulin Infusion (Human) 10%], 1 gram size. The unit carton text incorrectly states the storage temperature at room temperature as “up to 25°C (77°C)” instead of “up to 25°C (77°F)”.
Action	Please continue to use the GAMMAGARD LIQUID [Immune Globulin Infusion (Human) 10%], 1g product, if you have correctly stored the product. The product insert states the correct storage conditions, including at room temperature of “up to 25°C (77°F)”. As the Baxter supply chain assures the subject product is maintained at the correct storage temperature, the extent to which product may have been exposed to error on the unit carton (77C) is negligible. There have been no adverse events associated with this issue.
Other Information	If you have any questions, please call Baxter’s Customer Service unit at 1-800-423-2090.