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FDA MEDWATCH ALERTS

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January 12, 2012

Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient

Summary:

FDA notified health care professionals of the Class 1 recall of this product due to a manufacturing issue can stop delivering therapy to the patient. Part of the blower that circulates air and other gases through the ventilator may move out of position and cause the device to alarm.  Failure to respond could result in the potential for harm or death of a ventilator-dependent patient.

January 12, 2012

Bedford Laboratories Vecuronium Bromide And Polymyxin B For Injection USP For Injection: Recall - Glass Particles

Summary:

Bedford Laboratories issued guidance on the nationwide voluntary product recalls originally issued on August 2, 2011. The recalls were initiated after the discovery of a visible glass particle in a limited number of vials within the lots listed.

January 09, 2012

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk

Summary:

FDA is advising health care professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site.

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ASA FEATURED PRODUCT

Self-Education and Evaluation (SEE) Program

SKU: 30701-12CE

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Single Copies, Member Price: $300

Propofol Shortage Update and Resources

Chicago — (June 17, 2010) 

The recently expanded recall of certain lots of propofol by Hospira, coupled with the latest announcement from Teva that it will cease further production of propofol, has led to many questions and concerns regarding propofol supplies.

Please be advised that both the Food and Drug Administration (FDA) and ASA are aware of anesthesiologists’ concerns and the difficulty many individuals and facilities are experiencing in maintaining their propofol supplies. ASA has been in regular communication with FDA and APP (currently the sole supplier and importer of propfol) to address the shortage.

According to FDA officials, the Agency continues to authorize the importation of Fresenius Propoven 1% (propofol 1%) by APP. APP is also increasing production of APP Diprivan® and generic propofol. In addition, FDA is hopeful that Hospira will be releasing new product shortly, since the company has recently instituted manufacturing changes in an effort to alleviate previous production problems.

Individuals and facilities should still attempt to obtain propofol through their normal distribution chains. Those who are experiencing difficulties, however, may contact APP to arrange direct shipments.

As always it is important for FDA to understand the extent of all drug shortages. Therefore, if you or your facility are experiencing difficulty obtaining any medication, please contact the FDA Drug Shortage Division to let them know.

Contact information for the FDA’s Drug Shortage Division

Additional information on the propofol shortage from the FDA can be found at the following website, which also contains answers to some frequently asked questions.

FDA Propofol Shortage Website

THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS

Anesthesiologists: Physicians providing the lifeline of modern medicine. Founded in 1905, the American Society of Anesthesiologists is an educational, research and scientific association with 46,000 members organized to raise and maintain the standards of the medical practice of anesthesiology and improve the care of the patient.

For more information on the field of anesthesiology, visit the American Society of Anesthesiologists Web site at www.asahq.org. For patient information, visit LifeLineToModernMedicine.com

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Contact:

Jennifer Gremmels
j.gremmels@asahq.org
847-268-9128