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MEETINGS / EVENTS

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

ASA Quality Meeting 2014

June 26 - 28 2015, 12:00 AM - 12:00 AM

Annual Perioperative Surgical Home Summit

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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

41–60 of 141 results
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Friday, August 30, 2013

Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination

Wellness Pharmacy Inc Products Recall Laboratory Results Indicating Microbial Contamination

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Friday, August 30, 2013

JCB Laboratories Products: Recall - Sterility Assurance at Testing Vendor

JCB Laboratories Products Recall Sterility Assurance at Testing Vendor

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Tuesday, August 20, 2013

Aidapak Services LLC, Select Repackaged Pharmaceuticals: Recall - Potential Incorrect Labeling

Aidapak Services LLC Select Repackaged Pharmaceuticals Recall Potential Incorrect Labeling

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Wednesday, August 14, 2013

Hospira Blood Sets: Recall - Instances Of Outer Wall Of Blood Bags Punctured With Piercing Pin

Hospira Blood Sets Recall Instances Of Outer Wall Of Blood

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Monday, August 12, 2013

Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections

Specialty Compounding Sterile Products FDA Alert Bacterial Infections

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Friday, August 02, 2013

Beacon Hill Pharmacy d/b/a Rxtra Solutions Issues Voluntary Nationwide Recall of Certain Sterile Products Due to a Question of Sterility Assurance

Beacon Hill Pharmacy Voluntary Nationwide Recall of Certain Sterile Products 8-2-13

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Wednesday, July 24, 2013

MedStream Programmable Infusion Pump: Class 1 Recall - Malfunction In The Fill Level Sensor

MedStream Programmable Infusion Pump Class 1 Recall

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Tuesday, July 23, 2013

Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: Class 1 Recall - Mislabeled Packaging

Bryan Medical Tracoe Mini 30mm Tracheostomy Tube Class

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Monday, July 22, 2013

FDA Reports that 10 ML Vials of Succinylcholine (20mg/ml) are now Available

FDA Reports that 10 ML Vials of Succinylcholine are now Available

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Friday, June 21, 2013

FDA approves first genotyping test for patients with hepatitis C

FDA approves first genotyping test for patients with hepatitis C

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Thursday, June 13, 2013

Symbios GOPump and GOBlock Kits: Class 1 Recall - Potential for Excessive High Flow Rates

Symbios GOPump and GOBlock Kits Class 1 Recall

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Tuesday, June 11, 2013

Vecuronium Bromide For Injection by Sagent Pharmaceuticals, Inc.: Recall - Elevated Impurity Result Detected

Vecuronium Bromide For Injection by Sagent Pharmaceuticals Inc

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Friday, May 31, 2013

Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance

Olympia Pharmacy Sterile Compounded Products Recall

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