Reuters: Regulatory News: UPDATE 1-Hospira recalls electrolyte solution after mold found

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UPDATE 1-Hospira recalls electrolyte solution after mold found Jan 28th 2013, 22:05 Mon Jan 28, 2013 5:05pm EST * Solution used to replenish fluids, calories * No related injuries reported * Hospira investigating cause Jan 28 (Reuters) - Hospira Inc is recalling one lot of an intravenous electrolyte solution after the discovery of the presence of a substance that was consistent with mold, U.S. health regulators said on Monday. The Food and Drug Administration said the affected lot of the product, known as Lactated Ringer's and 5% Dextrose Injection, was distributed nationwide between June 2011 and January 2012 to wholesalers, hospitals and pharmacies. The FDA said the substance in the solution was discovered by a Hospira customer. The customer was not identified. Electrolyte solutions are used to replenish fluids and calories. One lot consists of more than 100,000 units, the company said. The FDA said Hospira has not received reports of any injuries to patients, but said contaminated solution could cause thrombosis, a type of blood clot; septic shock or fatal infection. The FDA said anyone with an existing inventory should stop use and distribution and quarantine the product immediately. "There have been no adverse events associated with this issue and we are conducting the recall voluntarily out of an abundance of caution," Hospira spokesman Dan Rosenberg said. "The action was due to one confirmed customer report and we continue to investigate the root cause," he said, adding that Hospira has not found any mold-like contamination in any of the samples it retained from the affected lot. Hospira's stock closed down about 2 percent at $34.40 on the New York Stock Exchange. Link this Share this Digg this Email Reprints

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