Common Variable Immunodeficiency Support Group
Common variable immunodeficiency (CVID) is a group of 20-30 primary immunodeficiencies (PIDs) which have a common set of symptoms but with different underlying causes. CVID's underlying causes are different, but the result of these are that the body doesn't produce sufficient antibodies in response to exposure to pathogens.
Everyone on Gammagard needs to check their log books - - you do keep an infusion log - don't you?
URGENT: BIOLOGIC MARKET WITHDRAWAL INFORMATION
Initiated by : Baxter Healthcare
Event Id : 141
Event Date : 05-28-2010
Therapy Gammagard Liquid
NDC Number Lot Number Size Packaging Expiration Date
0944270006 LE12J370AB 20.0 G Glass Vial 11-01-2012
0944270005 LE12J379AB 10.0 G Glass vial 11-01-2012
Reason The market withdrawal is being conducted as a precautionary measure due to an increased number of adverse event reports of allergic reactions associated with these two lots. Baxter places the health and well being of our patients and customers primary to all aspects of our business, and as such we are conducting this action.
Action 1) Please check all product labels against the list of affected lot numbers.
2) Do not take this product. Return affected recalled lots to the point of purchase to receive replacement product.
3) Contact your physician if you have medical questions.
Other Information If you need assistance, please call the Stericycle, Inc. at 1-888-UPDATE-U.
URGENT: BIOLOGIC MARKET WITHDRAWAL INFORMATION
Initiated by : Baxter Healthcare
Event Id : 141
Event Date : 05-28-2010
Therapy Gammagard Liquid
NDC Number Lot Number Size Packaging Expiration Date
0944270006 LE12J370AB 20.0 G Glass Vial 11-01-2012
0944270005 LE12J379AB 10.0 G Glass vial 11-01-2012
Reason The market withdrawal is being conducted as a precautionary measure due to an increased number of adverse event reports of allergic reactions associated with these two lots. Baxter places the health and well being of our patients and customers primary to all aspects of our business, and as such we are conducting this action.
Action 1) Please check all product labels against the list of affected lot numbers.
2) Do not take this product. Return affected recalled lots to the point of purchase to receive replacement product.
3) Contact your physician if you have medical questions.
Other Information If you need assistance, please call the Stericycle, Inc. at 1-888-UPDATE-U.
I was one of the unlucky victims, as I was told by the Doctors at the FDA of a "MANUFACTURING" problem that started in Lucerne..killed 2(both under the age of 15) and sent me into the hospital for open-heart surgery. I had one large clot on the left side of my heart and 2 auxiliary clots on the other side!
Even after getting copies of the FDA's AERS reports and seeing this irrefutable evidence...I could not get anyone in the IDF community to stand up to the drug company! After 2002 I truly never thought this could or would EVER happen again!!!! I guess a 1% death ratio is acceptable and my tiny ripple was shoved under the carpet!!