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MEETINGS / EVENTS

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

ASA Quality Meeting 2014

January 23 - 25 2015, 12:00 AM - 12:00 AM

ASA PRACTICE MANAGEMENT 2015

February 07 - 08 2015, 12:00 AM - 12:00 AM

ASA Certificate in Business Administration 2015

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FDA MEDWATCH ALERTS

October 20, 2014

Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter

Summary:

FDA Medwatch Alert 10-20-14

October 16, 2014

FDA MedWatch - LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage

Summary:

FDA MedWatch LifeCare Flexible Intravenous Solutions by Hospira Inc

October 13, 2014

FDA MedWatch - CareFusion EnVe and ReVel Ventilators: Class 1 Recall - Power Connection Failure

Summary:

FDA MedWatch CareFusion EnVe and ReVel Ventilators

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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

1–77 of 147 results
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Thursday, October 16, 2014

FDA MedWatch - LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage

FDA MedWatch LifeCare Flexible Intravenous Solutions by Hospira Inc

view details »

Monday, October 13, 2014

FDA MedWatch - CareFusion EnVe and ReVel Ventilators: Class 1 Recall - Power Connection Failure

FDA MedWatch CareFusion EnVe and ReVel Ventilators

view details »

Monday, October 13, 2014

FDA MedWatch - Oregon Compounding Centers, Inc. Unexpired Sterile Products: Recall - Lack of Sterility Assurance

FDA MedWatch Oregon Compounding Centers Inc Unexpired Sterile Products

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Tuesday, October 07, 2014

Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall - Incorrect Labeling

Ketorolac Tromethamine Injection USP 30mg ml by Sagent Pharmaceuticals Recall Incorrect Labeling

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Tuesday, June 17, 2014

FDA MedWatch - Smiths Medical Portex Low Dead Space Connector with Sideport, 3.5mm: Class I Recall- One Lot Mislabeled

Smiths Medical Portex Low Dead Space Connector with Sideport 3 5mm Class I Recall One Lot Mislabeled

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Wednesday, May 21, 2014

FDA MedWatch - Ventlab Resuscitator Bags: Recall - Possible Health Risk

FDA MedWatch Ventlab Resuscitator Bags Recall Possible Health Risk

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Friday, May 16, 2014

FDA MedWatch - Dobutamine Injection (250mg/20mL)/Hospira: Recall - Visible Particulates

FDA MedWatch Dobutamine Injection 250mg 20mL Hospira Recall Visible Particulates

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Monday, April 21, 2014

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

Lidocaine HCI Injection USP by Hospira Recall Visible Particulates

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Friday, April 18, 2014

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

Propofol Injectable Emulsion USP by Hospira Recall Visible Particulates

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Friday, March 28, 2014

FDA Update on the Shortage of Normal Saline

FDA Update on the Shortage of Normal Saline

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Tuesday, March 18, 2014

McKesson Technologies Anesthesia Care: Recall - Patient Case Data May Not Match Patient Data

McKesson Technologies Anesthesia Care Recall Patient Case Data May Not Match Patient Data

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Monday, February 10, 2014

Calcium gluconate 10 percent Injections by Rx Formulations: Recall - Microbial Contamination

Calcium gluconate 10 percent Injections by Rx Formulations Recall Microbial Contamination

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Monday, January 13, 2014

FDA Removes Unapproved Prescription Drug Products Containing Codeine and Dihydrocodeine from the Market

FDA Removes Unapproved Prescription Drug Products Containing Codeine and Dihydrocodeine

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Tuesday, November 26, 2013

Hospira GemStar Infusion System: Class I Recall - Pressure Sensor Calibration Drift

Hospira GemStar Infusion System Class I Recall Pressure Sensor Calibration Drift

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Monday, November 18, 2013

Nature's Pharmacy and Compounding Center Sterile Compounded Products: Recall - Lack of Sterility Assurance

Natures Pharmacy and Compounding Center Sterile Compounded Products Recall

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Friday, October 25, 2013

MedStream Programmable Infusion Pump and Refill Kits by Codman and Shurtleff: Class 1 Recall - Drug Over Infusion

MedStream Programmable Infusion Pump and Refill Kits by Codman and Shurtleff

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Monday, October 07, 2013

Emergency Cricothyrotomy Kit By H&H Medical Corporation: Recall - Defective Cuff Balloon On Endotracheal Airway

Emergency Cricothyrotomy Kit By HH Medical Corporation Recall Defective

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Monday, October 07, 2013

1 Percent Lidocaine HCL Injection By Hospira: Recall - Presence Of Dark Particulate

Lidocaine HCL Injection By Hospira Recall Presence Of Dark Particulate

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Wednesday, October 02, 2013

Carefusion Avea Ventilator: Recall - Underreporting Of Tidal Volume If used In Conjunction With Neonatal Hotwire Flow Sensor

Carefusion Avea Ventilato Recall Underreporting Of Tidal Volume If used In Conjunction

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Monday, September 23, 2013

Baxter Dual Luer Lock Caps: Class I Recall - Presence of Loose Particulate Matter Found In Packaging

Baxter Dual Luer Lock Caps Class I Recall Presence of Loose Particulate Matter Found In Packaging

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Friday, September 13, 2013

Leiter's Compounding Pharmacy: Recall - Concerns of Sterility Assurance

Leiters Compounding Pharmacy Recall Concerns of Sterility Assurance

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Thursday, September 12, 2013

GE Healthcare issues urgent medical device correction associated with all Tec 6 and Tec 6 Plus Vaporizers

GE Healthcare issues Urgent Medical Device Correction associated with all Tec 6 and

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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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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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