Labeling Error Spurs Recall of Baxter Biologic

Baxter Healthcare Corp. has recalled vials of GAMMAGARD LIQUID 10%, 20g, due to incorrect manufacturing and expiration dates.

PRODUCT / LOT NUMBER:
GAMMAGARD LIQUID, [Immune Globulin Intravenous (Human)] 10%, 20g size
Product Code 1502797
NDC # 0944-2700-06
 
MANUFACTURER:
Baxter Healthcare Corp.
Westlake Village, CA
 
REASON:
Baxter Healthcare Corp. 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.
 

Source: FDA

No votes yet