(Reuters) – The U.S. Food and Drug Administration has prohibited Hospira Inc from importing its Symbiq medication infusion pumps, which are manufactured in Costa Rica, into the United States, the company said Tuesday in a regulatory filing.
Hospira in the filing did not say why the FDA imposed the restriction. A Hospira spokesperson could not be immediately reached.
The company said the FDA’s action does not restrict importation of its other medication management products, and the company does not expect it will have a material impact on its ability to achieve its 2012 financial projections.
In August, Hospira announced it received a warning letter from the FDA over quality problems at the Costa Rica plant where it makes most of its infusion pumps. Among the issues cited were alarm failures on the company’s Plum brand of infusion pump.
At the time, the company said it was switching alarm components for the Plum pump, which was recalled in February 2011, and expected to complete that process by early 2013.
Hospira on November 7 said it had placed a voluntary hold on shipments of the Symbiq pumps to new U.S. customers. A day later, the FDA notified the company of the import restriction, Hospira said.
Last month, the FDA said some Symbiq models were recalled due to software issues after Hospira received reports from customers of touch screens that were not responsive, delaying therapy.
The Lake Forest, Illinois-based maker of medical devices and injectable specialty drugs said it will support the repair and replacement of Symbiq pumps to existing customers.
Hospira has been working for several years to resolve manufacturing issues at some of its plants. In February, it resumed production of injectable drugs at its Rocky Mount, North Carolina, plant after a maintenance shutdown. Manufacturing problems at that plant had let to shortages of anesthesia and other drugs for its customers.
Hospira shares were little changed in after-hours trading from Tuesday’s close of $ 29.60 on the New York Stock Exchange.
(Reporting by Susan Kelly in Chicago; Editing by Leslie Adler and Phil Berlowitz)
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Hospira says FDA blocks import of Symbiq infusion pump
