Hospira Recalls Propofol, Liposyn Due to Contamination
Company Recalls Drugs Made At Clayton Plant [The News and Observer, Raleigh, N.C.]
From News & Observer (Raleigh, NC) (April 17, 2010)
Apr. 17--Hospira has recalled two drugs made at its Clayton plant after federal regulators found problems at that facility and a factory in Rocky Mount.
The two drugs, an anesthetic agent called Propofol and an intravenous nutritional product called Liposyn, are sold to hospitals and physicians.
They were contaminated after an equipment failure at the Clayton facility.
The company received a warning letter from the U.S. Food and Drug Administration dated April 12 outlining "deficiencies related to particulate in certain emulsion products" at the Clayton facility, Hospira reported in a regulatory filing late Friday. The letter also discusses problems with manufacturing validation processes and quality control procedures.
The FDA letter does not restrict production or shipment of products made at the two plants, but Hospira is holding shipment of certain products pending its own investigation and discussions with the FDA, the company reported in its filing with the Securities and Exchange Commission.
"We are continuing to manufacture products at these plants," Hospira spokesman Dan Rosenberg said in a phone interview. "We take very seriously these comments from the FDA. We’re in the process of implementing the necessary improvements, and we’ll work closely with the agency to ensure we meet all its expectations as soon as possible."
Some of the problems also were found during inspections that took place a year ago, Hospira reported in its SEC filing.
The Rocky Mount plant employs about 2,000 people and makes a variety of injectable drugs and other medical products. The Clayton plant employs more than 300 and makes generic injectable drugs and nutritional products.
Hospira’s Clayton facility is part of an expanding pharmaceutical and biotechnology corridor in the Johnston County town that also includes a Novo Nordisk insulin factory and a Talecris Biotherapeutics facility that makes medicines from blood plasma.
Lake Forest, Ill.-based Hospira employs about 13,500 people worldwide and reported 2009 sales of $3.9 billion. The company has seven manufacturing facilities in the United States and six in other countries.
Hospira shares fell 67 cents Friday to close at $57.10 but are up about 80 percent in the past year.
The shares fell further in after-hours trading.
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Posted: April 2010
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