Hospira Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection Recall

The FDA posted a MedWatch Alert yesterday regarding a recall issued by Hospira Inc. involving one lot of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers. Some of the containers from this lot may be incorrectly labeled with the wrong bar code, which could potentially lead to a medication error.

The injection, which is mainly for intravenous (IV) use to help maintain electrolyte balance in the body, was distributed between July 2008 and September 2008.

Hospira indicates that while the product name and National Drug Code printed on the flexible plastic containers are correct, a small number may be incorrectly labeled with a bar code for 5% Dextrose Injection.

If a bar code system is used by the hospital or healthcare provider to confirm the medication, it could potentially result in a patient receiving the wrong drug.

Administering an injection of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride to an individual who is supposed to receive an injection of 5% Dextrose could cause potentially serious adverse reactions, including electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, parethesia or mental confusion.

The affected containers contain lot number 65-620-FW and expiration date May 1, 2010. The National Drug Code No. on the lot is NDC 0409-7902-09. It is packaged in 1000 mL flexible plastic containers.

 
According to a statement released by Hospira, no other lots are affected by the recall. They also indicate that they have identified the cause of the error and taken steps to prevent this type of error from occurring again.