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FDA MEDWATCH ALERTS

April 21, 2014

Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates

Summary:

Lidocaine HCI Injection USP by Hospira Recall Visible Particulates

April 18, 2014

Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates

Summary:

Propofol Injectable Emulsion USP by Hospira Recall Visible Particulates

April 18, 2014

FDA MedWatch - ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare: Class I Recall

Summary:

FDA MedWatch Class I Recall 4 18 14

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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 131 results
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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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Tuesday, May 28, 2013

Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections

Main St Family Pharmacy in TN FDA Alerts Adverse Reactions Steroid Injections

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Monday, May 20, 2013

All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance

All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility

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Tuesday, May 14, 2013

Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses

Zolpidem Containing Products Drug Safety Communication

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Thursday, May 09, 2013

The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products

The Compounding Shop FDA News Release Lack of Sterility

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Wednesday, May 08, 2013

Maquet SERVO-i Ventilator Battery Module: Class 1 Recall - Battery Run Time Shorter Than Expected

Maquet SERVOi Ventilator Battery Module Class 1 Recall Battery Run Time Shorter Than Expected

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Monday, April 29, 2013

Hospira Inc., GemStar Infusion System: Recall - Lithium Battery Low Voltage

Hospira Inc GemStar Infusion System Recall

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Monday, April 15, 2013

MedWatch March 2013 Safety Labeling Changes

Safety Labeling Changes

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