FDA PRESS RELEASE, FOR IMMEDIATE RELEASE — March 11, 2015 — LAKE FOREST, Ill. — Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary recall of one lot of Lactated Ringer’s Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report of several dark, fibrous particulates floating within the solution of the primary container. The particulate was confirmed as a common non-toxic, non-invasive mold, Aspergillus kanagawaensis. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.
A loss of sterility is a primary concern when there is a presence of mold in a sterile, nonpyrogenic solution. If contaminated solution is used on a patient it may cause bacteremia, sepsis, septic shock and endocarditis, and death may result. Signs and symptoms may include redness, pain, swelling at the site, fever, shortness of breath, tachycardia, nausea, and vomiting. Septicemia could lead to shock and multi-system organ failure, requiring critical medical intervention. The mold is considered allergenic and exposure to it may induce an allergic response or immune response to the particulate including anaphylaxis.
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