Hospira Gets FDA Warning Letter For Two Facilities
16 Abril 2010 - 6:55PM
Dow Jones News
Hospira Inc. (HSP) disclosed Friday that it recently received a
warning letter from the Food and Drug Administration related to
plants where it makes already-recalled dietary supplement and
anesthesia products that had issues with metal particles.
The products in question are called Liposyn and Propofol, which
Hospira voluntary pulled from the market in November. In a filing
with the Securities and Exchange Commission late Friday, Hospira
said the FDA letter covered two plants in North Carolina.
Warning letters can prove expensive and time-consuming to
resolve, and can also put a hold on FDA approval for products
related to the issues it found. Hospira said this letter doesn't
restrict production or shipping at the North Carolina plants, but
the company is holding shipment of certain products pending further
investigation and discussion with the FDA.
Hospira shares slipped 1.7% in after-hours trading Friday to
$56.11. Shares declined 1.2% during regular trading hours.
The Lake Forest, Ill., company also said it doesn't anticipate
these matters will adversely affect its ability to achieve its 2010
financial projections, although it said future regulatory action
from the FDA could have a material impact on results. The company
said it takes the matter seriously and intends to respond fully to
the agency.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com
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