Hospira Recalls Liposyn and Propofol for Suspected Metal Contamination

Hospira Inc. is recalling more than 150 lots of its Liposyn and Propofol Injectable products, which may be contaminated with tiny flakes of metal and pose a risk of death and serious injury to patients.

The company and the Food and Drug Administration are recalling 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30%. Also, 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80 are being recalled because some of the containers may contain particulate matter.

Liposyn is an intravenous fat emulsion product that is used to deliver calories to patients who require parenteral nutrition. The drug has been linked to deaths in some preterm infants who receive the injections.

Propofol is a powerful anesthetic used in surgeries to sedate patients. In June 2009, the drug was famously linked to the sudden death of pop singer Michael Jackson, who reportedly died after doctors used Propofol as a sleep aid.

Contamination Poses Risks to Patients

Tiny flakes of stainless steel shed from equipment used to manufacture the products have been detected in some lots of the drugs, prompting the larger recall, officials said.

The contaminants do not dissolve in the blood and can block blood flow, causing heart attack, stroke, respiratory failure, kidney failure, liver failure, and death, officials said. The tiny pieces of metal might also cause mechanical damage to the body in the form of Systemic Inflammatory Response Syndrome, the FDA warned.

Hospira, based in Lake Forest, Ill., has not received any reports of patient injuries or adverse events related to the contamination, the FDA said. The company has identified the source of the contamination and taken action to correct the problems and prevent such contamination in the future, officials said.

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