Injectable-drugs maker Hospira Inc HSP.N withdrew the 2013 profit and revenue outlook it gave on Wednesday after the U.S. health regulator imposed an import ban on some of its products.
Hospira shares were down about 8 percent at $30.15 in afternoon trade on the New York Stock Exchange, and fell as low as $29.84 earlier in the day.
The company, which had forecast adjusted earnings of $2.05 to $2.20 per share for 2013, said it expects the ban to hurt the earnings by 5 to 15 cents per share.
The maker of medical devices and injectable specialty drugs has been facing quality and manufacturing issues at some of its plants, leading to maintenance shutdowns and drug shortages.
The company has battled with issues as varied as presence of mold in certain injectable products, alarm failures in pumps, unresponsive touchscreens on its devices and software glitches.
On Wednesday, the Lake Forest, Illinois-based company said it had received a notice from the FDA over the quality of its devices.
"These issues have kept cropping up... they have been dealing with the problem on their drug side for a while. And now they know that they have to tackle the device side as well," Gabelli & Co analyst Kevin Kedra.
"I won't be surprised if there are more things that come to the surface. It's impossible to predict how long or how expensive it will be for them."
Hospira had faced quality concerns regarding one its key plants in Rocky Mount, North Carolina, which it had to temporarily shut down. The plant resumed production in February last year.
In August, the FDA issued another warning to the company, citing quality problems at its Costa Rican plant that makes most of its infusion pumps. The warning was followed by recalls of some models, and eventually, last November, the federal agency blocked the import of Hospira's Symbiq pump.
Wednesday's notification expanded the import alert issued on November 8, 2012 on the Symbiq pump.
The expansion also prohibited the import of its Plum, GemStar and LifeCare PCA infusion pumps, manufactured in Hospira's Costa Rica facility, into the United States.
(Reporting by Esha Dey in Bangalore; Editing by Roshni Menon and Sreejiraj Eluvangal)