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URGENT: BIOLOGIC RECALL INFORMATION
Initiated by :  Baxter Healthcare
Event Id :  151
Event Date :  03-14-2012
Therapy
Gammagard Liquid [Immune Globulin Intravenous (Human)] 10%
NDC Number Lot Number Size Packaging Expiration Date
0944-2700-06 LE12LG70AC 20g vial 11-25-2014
Reason Baxter Healthcare Corporation is voluntarily recalling lot LE12LG70AC of GAMMAGARD LIQUID, [Immune Globulin Intravenous (Human)] 10%, 20g size, product code 1502797, NDC# 0944-2700-06. This recall is being conducted as a precautionary measure due to a labeling error noted on the product vial label and unit carton. The labels on the unit carton and product vials indicate an incorrect manufacturing date and expiry date.

Incorrect Manufacturing Date: November 25, 2011
Incorrect Expiration Date: November 25, 2014

Correct Manufacturing Date: November 5, 2011
Correct Expiration Date: November 5, 2014

The Food and Drug Administration has been notified of this action.

Considering the information noted above, the medical assessment into this issue concluded that this labeling error poses negligible safety risk to the patient. This labeling error has no impact on the functionality of the product. Furthermore, stability data indicates the difference of 20 days between the correct expiry date and the printed expiry date has no impact on the product quality. Therefore, if you have already used this product no action is required. However, if you still have any inventory of this product lot, we are asking you to return the product.

Action 1) Please check all product labels against the affected lot number.
2) Do not take this product. Return affected recalled lots to the point of purchase to receive replacement product.
Other Information If you need assistance, please call Stericycle, Inc. at 1-888-873-2838.
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