Drugmaker Hospira Inc. has recalled some of its IV solution products due to a report of mold contamination which may endanger patients. The U.S. Food and Drug Administration announced that the recall impacts Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09.
Lactated Ringer's solution is used in IV drips to restore fluids in hospital patients experiencing severe blood loss after events such as surgery, traumatic accidents or burn injuries. Dextrose is a naturally occurring blood sugar that is similarly used in IVs to help stabilize a patient's blood nutrients. Patients with IVs using contaminated IV solutions may experience serious negative health consequences. The administration of defective drugs to any patient can be highly dangerous, but those in need of IV fluids tend to be a more vulnerable.
The FDA reports that Hospira's IV solution was recalled after a leak was discovered between the solution's primary container's protective cap. One consumer reported mold in the cap area, which could have been introduced back into the primary container or caused a patient to develop a serious infection at the site of the injection.
"If contaminated solution is used on a patient, critical patient harm may result," the FDA said in a recall notice. "Injections of mold could potentially lead to septicemia (blood stream infections), which in a worst-case scenario may have the potential to progress to septic shock, which may be life threatening. Signs and symptoms could include injection site reactions, fever, shortness of breath, fast heart rate and feeling generally ill with nausea and vomiting."
The recall impacts the entire country and the FDA has not received any reports of patient deaths related to the mold contamination issue.
Source: FDA, "Hospira Issues A Voluntary Nationwide Recall Of One Lot Of Lactated Ringer's And 5% Dextrose Injection, Usp, 1000 Ml, Flexible Containers Due To Mold Contamination."