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November 08 - 09 2014, 12:00 AM - 12:00 AM

ASA Quality Meeting 2014

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FDA Alerts and Recalls

AUDIENCE: Surgery, Anesthesia, Neurology, Healthcare Professionals

ISSUE: FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate collected from New England Compounding Center (NECC). FDA is in the process of conducting additional microbial testing to confirm the exact species of the fungus.

Investigation into the exact source of the outbreak is still ongoing, but the outbreak is associated with a potentially contaminated medication. That product is preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid produced and distributed by New England Compounding Center (NECC) in Framingham, Massachusetts. CDC’s interim data show that all infected patients received injection with this product.

BACKGROUND: FDA was been working closely with CDC, several state health departments, and the Massachusetts Board of Pharmacy to investigate the scope and cause of the outbreak of fungal meningitis. FDA inspectors in the New England District Office, in cooperation with the Massachusetts Board of Registration in Pharmacy have been conducting an inspection of the New England Compounding Center. The firm voluntarily ceased all operations and surrendered its license to the Massachusetts Board of Registration in Pharmacy on October 3, 2012.

RECOMMENDATION: Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time. In addition, FDA requests that health care professionals retain and secure all remaining products purchased from NECC until FDA provides further instructions regarding the disposition of these products.

Although the investigation into the source of the outbreak is still ongoing, if you have purchased a product from NECC, FDA is advising not to use it at this time. This includes all products compounded and distributed at NECC; not just the ones that have been recalled. Please see the CDC website for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

 

Download form

or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, incliding links to the FDA statement, Q&As, and list of recalled products, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm322849.htm


You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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Alerts By Date

125–139 of 139 results
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Wednesday, August 25, 2010

Ikaria® Recalls INOMAX® DS Drug-Delivery System

Ikaria® Recalls INOMAX® DS Drug-Delivery System

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Monday, August 02, 2010

Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms

Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms

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Monday, August 02, 2010

NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter

NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter

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Thursday, July 22, 2010

Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays

Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays

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Friday, July 09, 2010

Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism

Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism

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Thursday, May 13, 2010

GE Healthcare Aisys and Avance Anesthesia Systems: Recall

GE Healthcare Aisys and Avance Anesthesia Systems: Recall

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Friday, May 07, 2010

Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall

Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall

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Wednesday, May 05, 2010

Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change

Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change

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Tuesday, May 04, 2010

Baxter Colleague Infusion Pumps: FDA Ordering Recall

Baxter Colleague Infusion Pumps: FDA Ordering Recall

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Saturday, April 24, 2010

Coviden Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes

Coviden Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes

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Thursday, April 22, 2010

LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.

LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.

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Wednesday, February 10, 2010

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall

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