July 11, 2014 — One lot of Lactated Ringers and 5% Dextrose injection has been recalled because it may be contaminated with mold.
Recalled products include:
- Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09, Lot 35-118-JT, Expiration November 1, 2015.
The problem was discovered when a customer reported visible particulate matter. Upon closer inspection, it appeared to be a filament-like structure consistent with mold. The container was punctured in the same physical location.
The manufacturer, Hospira Inc., warns that the sterility of a leaky container of medicine cannot be guaranteed. If the leak is not discovered and the solution is administered to a patient, it could potentially cause a life-threatening hospital infection, especially in critically ill patients.
“Intravenous administration of a non-sterile product can result in infections that may be life-threatening, and may result in prolonged hospitalization or organ failure. Hospira has not received reports of any adverse events associated with this issue for this lot to date.”
Corrective actions have been implemented to address the problem. Samples that were retained from the affected lot did not show signs of quality-control problems.
The product is used in a hospital or clinical setting to replace lost fluids, electrolytes, and carbohydrate calories if necessary. It is packaged in 1000mL flexible bottles that are wrapped in plastic. They were distributed from December 2013 through February 2014.
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