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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 and Thiopental Supply Information

Chicago — (November 3, 2009) 

ASA has been in contact with the FDA and has communicated its concern about the simultaneous supply problems that are occurring with multiple induction agents in some parts of the country. According to the FDA’s Director of the Division of Anesthesia, Analgesia and Rheumatology Products in the Center for Drug Evaluation and Research, the FDA Drug Shortage Program is continuing to monitor the propofol and thiopental supply situation and is working with manufacturers to ensure that adequate product remains available.
 
Updated information can be found on the FDA’s website.
 
According to the FDA the three propofol manufacturers are currently reporting the following:
  • APP has Diprivan 10 mg/mL injection in 20 mL vials (NDC 63323-0269-20), 50 mL vials (NDC 63323-0269-50), 100 mL vials (NDC 63323-0269-65), 20 mL Novaplus vials (NDC 63323-0269-27), 50 mL Novaplus vials (NDC 63323-0269-57), and 100 mL Novaplus vials (NDC 63323-0269-67) and is currently allocating to conserve supplies and is increasing production and releasing additional propofol this week.  The firm anticipates that supplies will continue to improve over the next several weeks.
  • Hospira anticipates that the 20 mL and 100 mL vials will be released within two weeks, and the 50 mL vials have an estimated release date of early-December, 2009.
  • Teva plans to have product available again by the end of the year.
ASA will continue to work with the FDA to investigate and address this situation in order to minimize the impact on patient care.
 
If your hospital or practice is experiencing a drug shortage or a problem securing any drug, please contact the FDA Drug Shortage Group. Your report will help FDA address the problem more quickly for all.
 
Further, specific information can also be found at the following links for the American Society for Health-System Pharmacists:

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