Hospira Propofol Injectable Emulsion Recalled due to Defective Glass Vials

Risk Managers and Pharmacy healthcare personnel are informed by the FDA that Hospira Propofol Injectable Emulsion is recalled because of visible particles embedded in the glass which can cause serious adverse events.

Background of Hospira Propofol Injectable Emulsion

Propfol Injectable Emulsion, by Hospira, Inc. is used to induce or maintain anesthesia in surgical patients or for the sleep initiation in intensive care units. FDA Alert on Hospira Propofol Injectable Emulsion

FDA’s reason for the recall is that there are visible particles embedded in the glass of Hospira Propofol Injectable Emulsion. The particles can be dislodged in the solution and in case they are injected into a patient this can cause tissue necrosis in organ/s, chest pain that can lead to serious adverse events including stroke and renal failure.

The affected lots are:

• 07-893-DJ, expiration date: 01JUL2013
• 10-123-DJ, expiration date: 01OCT2013
• 10-125-DJ, expiration date: 01OCT2013

These lots were distributed from September 2011 through February 2012 to wholesalers and direct customers in the US.

Contacting the FDA to report cases of Hospira Propofol Injectable Emulsion

In case of detection of adverse events or side effects related to the use of Hospira Propofol Injectable Emulsion, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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