Litigation

Georgia/Florida:Hospira Issues Second Drug Recall in 6 Months on FDA Warning

By Mark Zamora

Hospira Inc. recalled two drugs for the second time in six months because of manufacturing defects that prompted an April 12 warning letter from the U.S. Food and Drug Administration, said Dan Rosenberg, a company spokesman.

The drugs -- Propofol, an anesthetic agent, and Liposyn, an intravenous nutritional product -- were recalled on April 1, Rosenberg said. The company told the FDA the products had been contaminated by particulates during the manufacturing process, he said. The drugs are sold to hospitals and doctors.

Liposyn II (Intravenous Fat Emulsion) is a sterile, nonpyrogenic fat emulsion for intravenous administration. It is supplied in both a 10% and 20% concentration.

Liposyn II 10% contains 5% safflower oil, 5% soybean oil, up to 1.2% egg phosphatides added as an emulsifier and 2.5% glycerin in water for injection. May contain sodium hydroxide for pH adjustment. pH 8.0 (6.0 — 9.0). Liposyn II 10% has an osmolarity of 276 mOsmol/liter (actual). The total caloric value of Liposyn II 10% including fat, phospholipid and glycerol is 1.1 kcal/mL. Of this total, approximately 0.6 kcal/mL is supplied by linoleic acid.

Liposyn II 20% contains 10% safflower oil, 10% soybean oil, 1.2% egg phosphatides and 2.5% glycerin in water for injection. May contain sodium hydroxide for pH adjustment. pH 8.3 (6.0 _ 9.0). Liposyn II 20% has an osmolarity of 258 mOsmol/liter (actual). The total caloric value of Liposyn II 20% including fat, phospholipid and glycerol is 2 kcal/mL. Of this total, approximately 1.2 kcal/mL are supplied by linoleic acid.

Both Liposyn II 10% and Liposyn II 20% contain emulsified fat particles of approximately 0.4 micron in diameter, similar to naturally occurring chylomicrons.

Full post as published by Trial Lawyer Resource Center on April 19, 2010 (boomark / email).