Mislabeling Leads to Potassium Chloride Injection Recall

Baxter International, Inc, is voluntarily recalling 1 lot of its highly concentrated potassium chloride injection due to mislabeling.

Baxter International, Inc, is voluntarily recalling 1 lot of its highly concentrated potassium chloride injection due to mislabeling.

The reason for the recall is that a lower dosage of the product, which treats potassium deficiency, could be administered as a result of the mislabeling.

A lower dosage of the product, which is administered intravenously, could cause life-threatening problems for patients prone to severe electrolyte imbalance, according to a press release from Baxter. However, no associated adverse events have yet been reported.

According to Baxter, some containers of Product Code 2B0826, Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL, Lot Number P319160 were incorrectly labeled on the overpouch as 20 mEq per 100 mL.

The recalled product has an expiration date of June 30, 2015, and was sold to consumers between June 23, 2014, and October 2, 2014.

Baxter is advising customers not to use the product and return the overpouches to the company for credit by calling Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7 am and 6 pm Central Time.

Any questions about the recall can be directed to Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8 am and 5 pm Central Time, or via email at onebaxter@baxter.com.

Individuals who experienced an adverse reaction to the overpouches can also report it to the FDA’s MedWatch by downloading a form at www.fda.gov/MedWatch/getforms.htm and submitting it online, or by requesting the form by phone at 1-800-332-1088 and mailing it in or submitting it via fax to 1-800-FDA-0178.