- From LexisNexis® Mealey’s™ Daily Legal News.
The Food and Drug Administration on Feb. 13 notified Hospira Inc. that the agency has expanded its prohibition against the importation of the company’s Symbiq infusion pumps to include its Plum, GemStar and LifeCare PCA infusion pumps made in Hospira’s Costa Rica manufacturing plant.
Hospira reported the expanded import restriction in a Feb. 13 Form 8-K filed with the U.S. Securities and Exchange Commission.
“The Company intends to support the repair and service of all impacted pumps to existing customers,” Hospira said.
2013 Sales To Take Hit
However, the FDA’s action prompted Hospira to withdraw its 2013 financial projection, which was issued earlier on Feb. 13. The company said it now estimates that the import restrictions could reduce this year’s net sales by $ 50 million to $ 100 million.
In August, the FDA sent Hospira a warning letter about quality problems involving the four infusion pumps made at the Costa Rica plant. The pumps have been the subject of at least two recalls.