Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling

[Posted 09/17/2014]

AUDIENCE: Pharmacy, Risk Manager, Nursing

ISSUE: Baxter International Inc. announced a voluntary recall of one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826 (Lot # P318220, NDC # 0338-0709-48) to the hospital/pharmacy/nurse level. The recall is being initiated due to a labeling error on the shipping cartons in a single lot. 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.

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. There have been no reported adverse events associated with this situation to date.

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

RECOMMENDATION: It is recommended that healthcare professionals carefully review the product label before administering.

Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[09/16/2014 - Firm Press Release - Baxter International, Inc]