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MEETINGS / EVENTS

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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

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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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Monday, January 07, 2013

Fisher and Paykel Healthcare Reusable Breathing Circuit Class I Recall - Pinholes in Tubes

Fisher and Paykel Healthcare Reusable Breathing Circuit Class I Recall - Pinholes in Tubes

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Friday, November 30, 2012

Mindray A3 and A5 Anesthesia Delivery System: Class I Recall - Gasket Leak

Mindray A3 and A5 Anesthesia Delivery System

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Friday, November 09, 2012

Baxter Healthcare Corp. Buretrol Solution Sets: Class 1 Recall - May Not Function as Expected

Baxter Healthcare Corp Buretrol Solution Sets

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Thursday, November 01, 2012

Fungal Meningitis Outbreak Laboratory results from samples of two additional recalled NECC products

Fungal Meningitis Outbreak Laboratory results from samples of two additional recalled NECC products

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Monday, October 22, 2012

Fungal Meningitis Outbreak: FDA Provides NECC Customer List

Fungal Meningitis Outbreak FDA Provides NECC Customer List

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Thursday, October 18, 2012

FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised - Update

FDA Statement on Fungal Meningitis Outbreak Additional Patient Notification Advised Update

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Monday, October 15, 2012

FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised

FDA Statement on Fungal Meningitis Outbreak Additional Patient Notification Advised

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Monday, October 08, 2012

New England Compounding Center (NECC): Potentially Contaminated Medication Fungal Meningitis Outbreak

New England Compounding Center Potentially Contaminated Medication Fungal Meningitis Outbreak

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Friday, August 17, 2012

Hospira Hydromorphone Hydrochloride Injection

Hospira Hydromorphone Hydrochloride Injection

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Friday, August 17, 2012

Hospira Propofol Injectable Emulsion: Recall- Glass Vial Defect

Hospira Propofol Injectable Emulsion

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Friday, June 29, 2012

Ondansetron (Zofran) IV: Drug Safety Communication - QT prolongation

Ondansetron (Zofran) IV: Drug Safety Communication - QT prolongation

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Wednesday, May 16, 2012

Hydromorphone Hydrochloride Recall

Hydromorphone Hydrochloride Recall

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Wednesday, April 18, 2012

Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall - May Contain More Than Intended Fill Volume

Customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume. Opioid pain medications such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.

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Monday, March 05, 2012

Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall - Defective Component

FDA notified healthcare professionals and medical care organizations of the Class 1 recall of the listed AEDs which contain a component that may fail unexpectedly due to a defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy, causing serious adverse health consequences, including death. The unit’s self test may not detect the failure or impending failure of the component.

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Friday, February 24, 2012

Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes: Class 1 Recall - Inadvertent Dislodgement

FDA notified healthcare professionals and medical care organizations about the Class 1 recall of certain lots of these tracheostomy tubes. Difficulty arising from disconnecting accessories from the connectors of the affected tubes may result in excessive force to detach the accessory and the tracheostomy tube may dislodge from the patient. This could lead to serious patient injury or death, especially if no replacement tube is immediately available.

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Monday, January 09, 2012

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk

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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Wednesday, January 04, 2012

Ikaria INOmax DS Drug Delivery System: Class I Recall - Erratic Nitric Oxide (NO) Readings

FDA notified healthcare professionals of a Class I recall of Ikaria INOmax DS Drug Delivery System. Erratic nitric oxide (NO) monitoring readings were being caused by fretting corrosion at the electrical contact interface of certain metals.

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Friday, December 23, 2011

CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation

FDA notified health care professionals of a class I recall of CareFusion AVEA Ventilators. The AVEA ventilator can develop a failure where the ventilator activates a false extended high peak alarm, opens the safety valve and stops ventilating. Without health care professional intervention, patients may suffer life-threatening injury or death.

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Friday, November 04, 2011

CareFusion EnVe Ventilators: Class I Recall - Potential for Interruption of Patient Ventilation

FDA notified health care professionals of a Class I recall of all EnVe Ventilator model 19250-001, manufactured between December 2010 and May 2011, due to potential defects that can interrupt ventilation to the patient.

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Monday, September 12, 2011

Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class I Recall - Potential for Reduced Battery Performance

Medtronic and FDA notified healthcare professionals of a Class I recall of the SynchroMed II Infusion system. Medtronic’s analysis of the problem indicates it is related to the formation of a film within the pump battery. This problem can lead to the sudden loss of therapy and the return of underlying symptoms and/or therapy withdrawal symptoms.

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Wednesday, August 03, 2011

GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH): Class I Recall

FDA notified healthcare professionals of a Class I recall of GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH) for Vital Signs Anesthesia Breathing Circuits. The HCH device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient.

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Monday, June 27, 2011

Butalbital, Acetaminophen, and Caffeine Tablets (USP 50mg, 325mg, 40mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg): Recall - Bottle Mislabeled

Qualitest and FDA is notifying pharmacists and patients of a recall to the retail level of specific lots of Butalbital, Acetaminophen, and Caffeine Tablets and Hydrocodone Bitartrate and Acetaminophen Tablets due to possibility that the recalled bottles may contain incorrect tablets, and patients may unintentionally take butalbital and caffeine instead of hydrocodone.

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Monday, June 27, 2011

Endocet (Oxycodone / Acetaminophen) Tablets, ( 10mg, 325mg ) : Recall - Some Bottles Contain Different Strength Tablets

Endo Pharmaceuticals and FDA notified pharmacists and patients of a nationwide consumer level recall of Endocet (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg because some bottles may contain different strength tablets, resulting in patients taking more than the intended acetaminophen dose.

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Tuesday, June 07, 2011

Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall - Plastic Strands on the Adapter May Become Dislodged, Inhaled by Patient

Fine plastic strands on the inner surface of the infant/neonatal airway adapter may become dislodged and inhaled by the patient. Inhalation of the plastic strands on the defective devices may cause respiratory compromise, which could result in serious illness or death.

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Tuesday, May 10, 2011

Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall - Software Defect May Cancel Shock

Devices subject to this recall include Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient.

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Thursday, March 03, 2011

Cook Inc., Central Venous Catheter Trays

FDA notified healthcare professionals of leaks in the plunger luer detected during a routine syringe leak test. The potential exists for leakage and possible loss of sterility. This may lead to serious adverse health consequences and/or death.

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