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FDA Safety Warning: Mold Contamination in Lactated Ringer’s Irrigation

Hospira issues nationwide recall

According to the FDA, Hospira has initiated a voluntary recall of one lot of lactated Ringer’s irrigation, 3,000 mL (NDC: 0409-7828-08; lot 40-008-JT, expiry 1APR2016) to the user level (both human and veterinary) because of a confirmed customer report of several dark, fibrous particulates floating within the solution of the primary container. The particulate was confirmed as a common nontoxic, noninvasive mold, Aspergillus kanagawaensis.

If contaminated solution is used on a patient, it may cause bacteremia, sepsis, septic shock, and endocarditis, and death may result, the FDA warns. 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 multisystem organ failure, requiring critical medical intervention. The mold is considered allergenic, and exposure to it may induce an allergic or immune response to the particulate, including anaphylaxis. Delayed therapy may occur if the particulate were to block the flow of the solution during irrigation.

Lactated Ringer's irrigation is a sterile, nonpyrogenic solution of electrolytes in water for injection, intended only for sterile irrigation, washing, and rinsing purposes. The product is packaged in 3,000-mL flexible container bags and is sold four bags per carton.

The affected lot was distributed nationwide in the U.S to wholesalers, distributors, surgery centers, and hospitals from June 2014 through September 2014. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

The FDA recommends that anyone with an existing inventory of the recalled lot should stop use and distribution, and should quarantine the product immediately. Customers should notify all users in their facility. Customers who have further distributed the recalled product should notify any accounts or additional locations that may have received the recalled product and should instruct them, if they have redistributed the product, to notify their accounts, locations, or facilities to the user level (both human and veterinary).

Hospira will be notifying its direct customers via a recall letter and is arranging for affected product to be returned to Stericycle in the U.S.

Source: FDA; March 12, 2015.

 

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