Baxter Recalls Select Lots of Injectables

Baxter International Inc. announced on December 23 that it has initiated a voluntary recall to the hospital/user level of one lot of 5% Dextrose Injection, USP and four lots of 0.9% Sodium Chloride Injection, USP due to particulate matter found in the solutions.

Dextrose Injection, USP is an intravenously administered injectable indicated as a source of water and calories. Sodium Chloride Injection, USP is an intravenously administered injectable indicated as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures. These 50 mL and 100 mL containers are primarily used for admixture of medication and as priming solutions. The product codes affected by this recall are found in the table below:

PRODUCT NAME PRODUCT CODE NDC CONTAINER SIZE LOT # EXP.
5% Dextrose Injection, USP 2B0089 0338-0017-38 100 mL P285288 Nov-13
0.9% Sodium Chloride Injection, USP 2B1308 0338-0049-31 50 mL P297283 Aug-14
0.9% Sodium Chloride Injection, USP 2B1302 0338-0049-18 100 mL  P292326 Apr-14 
        P293993 May-14 
0.9% Sodium Chloride Injection, USP 2B1309 0338-0049-38 100 mL P293514 Apr-14

 

There have been no reported adverse events associated with this issue to date, and the root cause of this recall has been identified and resolved.

Read the FDA press release

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