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MEETINGS / EVENTS

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May 05 - 07 2014, 12:00 AM - 12:00 AM

2014 ASA Legislative Conference

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FDA MEDWATCH ALERTS

March 28, 2014

FDA Update on the Shortage of Normal Saline

Summary:

FDA Update on the Shortage of Normal Saline

March 18, 2014

FDA MedWatch - Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine

Summary:

Merit Medical Systems Custom Procedural Trays Kits Recall Particulates Found in Hospira Lidocaine

March 18, 2014

McKesson Technologies Anesthesia Care: Recall - Patient Case Data May Not Match Patient Data

Summary:

McKesson Technologies Anesthesia Care Recall Patient Case Data May Not Match Patient Data

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Self Education and Evaluation (SEE) Program

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Update on Propofol Shortage and Importation of Fresenius Propoven 1% (propofol 1%)

Chicago — (March 16, 2010) 

 


FDA Authorizes APP to Resume Importation of Fresenius Propoven 1% (propofol 1%) to Alleviate Ongoing Shortage of Propofol Injection in the United States

Due to the ongoing critical shortage of Propofol Injection in the United States, and in conjunction with the FDA, APP has been authorized to reintroduce Fresenius Propoven 1% (propofol 1%) to the US market. APP will also continue to offer DIPRIVAN® (propofol 1%) and increase supply of APP Propofol 1% (authorized generic DIPRIVAN).

FDA previously granted APP approval to import and distribute Fresenius Propoven 1% (propofol 1%) to help alleviate shortages following two voluntary recalls from other manufacturers of propofol injection. This temporary importation ended on February 1, 2010 and has now been reinstated to alleviate the ongoing shortage following continued supply issues from other manufacturers. APP has indicated that it is committed to providing the US market with available quantities of Fresenius Propoven 1% (propofol 1%), DIPRIVAN® (propofol 1%) and APP Propofol 1% (authorized generic DIPRIVAN®) and anticipates Fresenius Propoven (propofol 1%) will be used to address the shortage until the marketplace stabilizes. Fresenius Propoven 1% (propofol 1%) is manufactured by APP’s parent company Fresenius Kabi AG, in FDA compliant facilities.

Please see the following “Dear Healthcare Professional” letter or the FDA’s website for more information.

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm#propofol.

THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS

Founded in 1905, the American Society of Anesthesiologists (ASA) is an educational, research and scientific society with more than 50,000 members organized to raise and maintain the standards of the medical practice of anesthesiology. ASA is committed to ensuring that physician anesthesiologists evaluate and supervise the medical care of patients before, during, and after surgery to provide the highest quality and safest care that every patient deserves.

For more information on the field of anesthesiology, visit the American Society of Anesthesiologists online at asahq.org. To learn more about the role physician anesthesiologists play in ensuring patient safety, visit asahq.org/WhenSecondsCount. Join the ANESTHESIOLOGYTM 2013 social conversation today. Like ASA on Facebook, follow ASALifeline on Twitter and use the hashtag #ANES2013.

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Contact:

American Society of Anesthesiologists
communications@asahq.org
847-825-5586