URGENT: BIOLOGIC RECALL INFORMATION

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> URGENT: BIOLOGIC RECALL INFORMATION Incorrect manufacture and expiration

dates

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> Initiated by : Baxter Healthcare

> Event Id : 151

> Event Date : 03-14-2012

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> Therapy: Gammagard Liquid [immune Globulin Intravenous (Human)] 10%

> NDC Number 0944-2700-06

> Lot Number LE12LG70AC

> Size 20g

> Packaging vial

> Expiration Date 11-25-2014

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> 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.

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> Incorrect Manufacturing Date: November 25, 2011

> Incorrect Expiration Date: November 25, 2014

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> Correct Manufacturing Date: November 5, 2011

> Correct Expiration Date: November 5, 2014

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

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> 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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