DATE RECALL INITIATED: March 6, 2012
PRODUCT / LOT NUMBER:
GAMMAGARD LIQUID, [Immune Globulin Intravenous (Human)] 10%, 20g size
- Product Code 1502797
- NDC # 0944-2700-06
Baxter Healthcare Corporation
Westlake Village, CA
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
Considering the information noted above, the medical assessment into this issue concluded 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 customers have already used this product, no action is required. However, customers having remaining inventory are asked to return the product to Baxter.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.