USFDA CDER Volunteer Recall Alert : Baxter Initiates U.S. Voluntary Recall of One Lot of Potassium Chloride Injection Due to Shipping Carton Mislabeling

Baxter International Inc. announced today it is voluntarily recalling one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826 to the hospital/pharmacy/nurse level. The recall is being initiated due to a labeling error on the shipping cartons in a single lot, which was identified by three customers.

Shipping cartons labeled for this specific lot number of Potassium Chloride Injection may contain units of Gentamicin Sulfate Injection, 80 mg in 100 mL, product code 2B0862.

Potassium Chloride is indicated for treatment of potassium deficiency and administered intravenously. Gentamicin Sulfate is an antibacterial drug for intravenous administration.

As both products are packaged in 100mL containers, have similar code numbers and red labeling on the front panel, there is a potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride.

The affected lot of Potassium Chloride Injection was distributed to customers in the United States between May 26, 2014, and August 8, 2014.

This recall affects the following lot of Potassium Chloride Injection 10mEq per 100mL:

Product Code	Description	Lot #	NDC #
2B0826	Potassium Chloride Injection 10mEq per 100mL	P318220	0338-0709-48

As part of standard clinical practice, it is recommended that healthcare professionals carefully review the product label before administering. There have been no reported adverse events associated with this situation to date.

For Detailed Information on Recall CLICK HERE