Current
Archive (Prior to 2010)

The U.S. Food and Drug Administration (FDA), in addition to private companies, often issue product recalls, reviews, and/or advisories that affect the dialysis community. Some recalls may relate to equipment malfunctions or hazards, or even medication administration or dosage. MARC relays all recalls or warning as we are apprised. Methods of notification include, but are not limited to, posting links to the appropriate notice on the MARC website; emailing, faxing, or mailing notices to facility personnel; and publication in the Network's INFORMED and/or REMARCS newsletters.

Current Alerts & Recalls

Below are links to the most recent recalls, reviews, and advisories affecting the dialysis community:

Baxter Bio-Science Initiates Market Withdrawal of GammaGardLiquid, Immune Globulin Intravenous (Human) due to Adverse Allergic Reactions (6/2010)

Voluntary Recall of Defibtech DBP-2800 Battery Packs for Lifeline and ReviveR AEDs – May Provide False Error Canceling Therapy (6/2010)

Summary of MedWatch Safety Alerts for May 2010

Blacksmith Brand Recalls Four (4) PediaCare Children's Products Manufactured by McNeil (5/2010)

Changes to Benadryl Extra Strength Itch Stopping Gel in Order to Reduce the Risk of Errors (5/2010)

Voluntary Recall of Metronidazole Injection 500mg/100ml Due to Non-Sterility (5/2010)

Warnings Strengthened for Ultram (tramadole hydrochloride) and Ultracet (tramadole hydrochloride/acetaminophen) (5/2010)

Labeling Changes to Proton Pump Inhibitors (PPIs) to Include Risk of Fractures – this class of drug includes Nexium, Dexilant, Prilosec, Prilosec OTC, Zegerid, Zegerid OTC, Prevacid, Prevacid 24-hour, Protonix, Aciphex, and Vimovo (5/2010)

*UPDATE – FDA Orders Recall and Destruction of Devices* Class I Recall*: Baxter Colleague Infusion Pumps (5/2010) 

FDA Conducts Safety Review of GnRH Agonists, a Drug Class Used to Treat Prostate Cancer (5/2010)

VitaBreath Dietary Supplements May Contain Hazardous Levels of Lead (5/2010)

Summary of MedWatch Safety Alerts for April 2010

McNeil Consumer Healthcare and FDA Recall Over-the-Counter Pediatric and Infant Liquid Products (4/2010)

*UPDATE – New Models Added * Class I Recall*: Cardiac Science Issues Voluntary Recall of Powerheart, Cardiovive, CardioLife, Nihon Kohden, and GE Responder AEDs for Failure to Deliver Therapy During Resuscitation Attempts (4/2010)

*UPDATE* Heparin Sodium USP Monograph Public Health Alert (4/2010)

Voluntary Recall of Camolyn Eye Drops & Fisiolin Nasal Drops Due to Non-Sterility (4/2010)

Undeclared Drug in Stud Capsule for Men: May Affect Those Taking Nitrates (4/2010)

Inhalers Using Chloroflourocarbons (CFCs) Being Phased Out (4/2010)

New Boxed Warning: Severe Liver Injury and Acute Liver Failure Reported with Propylthiouracil (4/2010)

*UPDATE* Class I Recall: Physio-Control Inc. LifePak 15 Monitor/Defribrillator (4/2010)

Safety Labeling Changes Approved by the FDA – March 2010 - These changes affect 40 drug products with safety label sections of: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

Cleviprex Recall Expanded (3/2010)

Zocor (simvastatin) Recalled Due to Increase Risk of Muscle Injury (3/2010)

Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) (3/2010)

FDA Updated Medication Guides (3/2010)

FDA List of Authorized Generic Drugs (3/2010)

Asclera Approved by the FDA to Treat Small Varicose Veins (3/2010)

FDA Adds Box Warning to Plavix (clopidogrel): Reduced Effectiveness in Some Patients (March 2010)

Particulates Found in Cleviprex (clevidipine butyrate): 15 Lots Affected (March 2010)

Safety Labeling Changes Approved by the FDA – February 2010 - These changes affect 24 drug products with safety label sections of: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

Class I Recall: StatSpin Express 4 Centrifuges Model #510, Serial Numbers 00100 through 001679 (2/2010)

Class I Recall: Baxter HomeChoice and HomeChoice Pro Automated Peritoneal Dialysis Sytems (2/2010)

LifeScan and the FDA Issue Voluntary Recall of OneTouch SureStep Glucose Measuring Test Strips (2/2010)

Cardiac Science Issues Voluntary Recall of Powerheart, Cardiovive, and CardioLife AEDs for Failure to Deliver Therapy During Resuscitation Attempts (2/2010)

Becton, Dixinson and Company (BD) Announces Worldwide Voluntary Recall ofBD Q-Syte™ Luer Access Devices and BD Nexiva™ Closed IV Catheter Systems (2/2010)

Acacia, Inc. Announces Worldwide Voluntary Recall of IV Extension Sets with BD Q-Syte™ Luer Access Device (2/2010)

*UPDATE* Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication (2/2010)

Boxed Warning for Exjade (deferasirox): May Cause Renal Impairment, Hepatic Impairment, and/or Gastrointestinal Hemorrage (2/2010)

New Safe Use Requirements for Long-Acting Beta-Agonists (LABAs) (2/2010)

Medication Use Errors with Maalox Total Relief and Maalox Liquid Antacid Products (2/2010)

Class I Recall:  Edwards Lifesciences Issues Recall of Aquarius Hemodialysis Systems (2/2010)

Summary of MedWatch Safety Alerts for January 2010

Class I Recall:  Exel/Exelint Huber Needles Manufactured by Nipro Medical Corporation for Exelint International Corporation (1/2010)

Class I Recall:  Hettich Centrifuges with 2050 and 2076 Plastic Rotors (1/2010)

FDA Drug Safety Announcement: Serious Liver Disorder Associated with Videx /Videx EC (didanosine) (1/2010)

Nipro Medical Corporation Voluntarily Recalls All GlucoPro Insulin Syringes (1/2010)

Counterfeit Version of Weight Loss Drug Alli (1/2010)

 

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Archive of Alerts & Recalls

For additional recall notices issued prior to 2010, please click here to be routed to the Alerts & Recalls Archive.

For additional recall, review, or advisory information not listed here, visit the FDA's MedWatch Safety Information and Adverse Reporting Program web site.

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