Michigan Immunodeficiency foundation

URGENT: BIOLOGIC RECALL
 
Initiated by :   Baxter Bioscience
Event Id :  121
Event Date :   06-24-2004
patient notification system
Product
Gammagard S/D Immune Globulin Intravenous (Human), Solvent Detergent Treated
NDC Number Lot Number Size Packaging Expiration Date
0944-2620-04 LE08D030AA 10g glass vials 03-30-2006
Reason This market withdrawal is being conducted as a precautionary measure due to an increased number of adverse event reports associated with allergic reactions.
Action 1) Please check all product labels against the list of affected lot numbers.
2) Do not take this product. Return affected product 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 NNC Group at 1-888-UPDATE-U.

URGENT: BIOLOGIC RECALL
 
Initiated by :  Aventis Behring
Event Id :  120
Event Date :  04-01-2004
patient notification system
Product
Gammar®-PIV
NDC Number Lot Number Size Packaging Expiration Date
0053-7486-10 A639110 10 gm - 10-23-2006
0053-7486-10 A639210 10 gm - 10-23-2006
Reason Aventis Behring L.L.C. (a ZLB Behring company) has voluntarily decided to initiate a recall of Gammar®-P I.V., lots A639110 and A639210, both with expiration dates of October 23, 2006. This action is being taken with the knowledge of the Food and Drug Administration.

Lots A639110 and A639210 are being recalled because they exhibit an increased frequency of non-serious, labeled adverse events of an allergic type, principally hives. There has also been one report of angioedema.

These batches were distributed by Aventis Behring between March 1 and March 23 of 2004.
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 have any questions concerning product returns, please call Aventis Behring Customer Support at 1-800-683-1288. For Medical Information questions, please call 1-800-504-5434.

If you need assistance, please call the NNC Group at 1-888-UPDATE-U.