Mold Contamination Leads to Hospira Lactated Ringer Recall

A recall has been issued for a caloric fluid and electrolyte replenishment supplement manufactured by Hospira, after mold contamination was discovered that could cause life-threatening injuries. 

A Hospira Lactated Ringer’s and 5% Dextrose Injection, USP, 1000 mL recall was announced October 5, after reports indicated that a leak between the cobra cap and fill-tube seal may be contaminated with mold.

The container of the fluid has an overwrap that may not be sterile, and when this fluid leaks, it may become trapped within the container and the overwrap, allowing for moisture to enter the pathway and cause mold to possibly be administered to the consumer.

The affected injection fluid was distributed throughout the U.S., except for Alaska, between January 2012 and June 2012. Recalled products have an NDC# and Batch# 0409-7929-0912-160-JT, which may also be followed by 01 or 09. The packaging contains an expiration date of December 1, 2013.

Mold ingestion can cause serious adverse consequences that may be life threatening. In many, case mold ingestion symptoms will surface within 12-24 hours after exposure, causing abdominal cramps, persistent diarrhea, dehydration, nausea, or an overall upset stomach.

Intravenously ingested mold could also potentially lead to septicemia, which can progress to septic shock causing a sometimes fatal blood stream infection.

Hospira has initiated an investigation that is still ongoing to determine the cause of defective product and solutions to prevent harm to their consumers. For medical inquiries consumers can contact 1-800-615-0187 or to report adverse events visit www.fda.gov/medwatch/report.htm.