Alerts & Recalls

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Alerts & Recalls

Current
Archive (Prior to 2009)

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:

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)

Safety Labeling Changes Approved by the FDA – December 2009 - These changes affect 28 drug products with safety label sections of: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

Changes to the prescribing information for Rapamune (sirolimus) (12/2009)

McNeil Consumer Healthcare and the U.S. Food and Drug Administration (FDA) Recall All Lots of Tylenol Arthritis Pain Caplets 100-Count Bottles (12/2009)

Safety Labeling Changes Approved by the FDA – November 2009
These changes affect 44 drug products with safety label sections of: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

FDA Seeks Additional Information about Ineffectiveness of External Biphasic Defibrillators That Deliver Energy levels = 200 Joules (J), including Monitor/Defibrillators and Automated External Defibrillators (AEDs) (11/2009)

To report a possible event, contact the FDA:
• online at MedWatch Safety Information and Adverse Event Reporting Program
• by phone at 1.800.332.1088
• by returning the postage-paid FDA form 3500 by mail to the address on the form or by fax at 1-800-FDA-0178.

Norpramin (desipramine hydrochloride) – Changes to Warnings and Overdose Prescribing Information (11/2009)

Foreign Particle Contamination in Several Genzyme Products, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen (11/2009)

Cardiac Science Corporation Receives Multiple Complaints about Powerheart and CardioVive Automated External Defibrillators (AEDs) (11/2009)

Revisions to Prescribing Recommendations for Byetta (exenatide) - Alters Kidney Function (11/2009)

Hospitals Granted Emergency Use Authorization (EUA) for Investigational Antiviral Drug Peramivir IV (10/2009)

Rituxan (rituximab) Linked to Progressive Multifocal Leukoencephalopathy (PML) (10/2009)

Accusure Insulin Syringes (Qualitest Pharmaceuticals) Recalled (10/2009)
All syringes, regardless of lot number, distributed between January 2002 and October 2009 are subject to this recall.

Medical Device Power Cord Safety Investigation (10/2009)

Dexferrum (Iron Dextran Injection) – Labeling Change (10/2009)

Worldwide Recall of Select Phillips Heartstart Fr2+ Automated External Defibrillators (AEDs) (10/2009)

Unomedical Manual Pulmonary Resuscitator - Recall (10/2009)

FDA Public Health Alert: Change in Heparin USP Monograph (10/2009)

Safety Labeling Changes Approved by the FDA – September 2009
These changes affect 36 drug products with safety label sections of: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

Nationwide Voluntary Recall of Children's and Infant's Tylenol Oral Suspension Products (9/2009)

FDA Warns of Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution (9/2009)

Revisions to Prescribing Information for Sitagliptin (marketed as Januvia and Janumet) - Reported Cases of Acute Pancreatitis (9/2009)

Public Health Alert: Potential Dosing Errors with Tamiflu (Oseltamivir) for Oral Suspension (9/2009)

Class I Recall: Physio –Control Inc. LIFEPAK CR Plus Automated External Defibrillators (AEDs) (9/2009)

*UPDATE* Novartis Notification to Healthcare Professionals Regarding Myfortic (mycophenolic acid): Change in Prescribing Information – Postmarket Reports of Pure Red Cell Aplasia (PRCA) (9/2009)

Safety Labeling Changes Approved By the FDA – August 2009
These changes affect 35 drug products with safety label sections of: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

*UPDATE*Stolen Levemir Insulin made by Novo Nordisk Inc. may still be on the market (8/2009)

*UPDATE* Roche Notification to Healthcare Professionals Regarding CellCept (mycophenolate mofetil): Pure Red Cell Aplasia (PRCA) in Patients Treated with CellCept (8/2009)

Unlawful Over-the-Counter Topical Drug Products Containing Ibuprofen (8/2009)

FDA Public Health Notification: Potentially Fatal Errors with GDH-PQQ* Glucose Monitoring Technology (8/2009)

Class 1 Recall: Alaris System by Cardinal Health/CareFusion – Various Modules (8/2009)

Safety Labeling Changes Approved By the FDA – July 2009
These changes affect 38 drug products with safety label sections of: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

Stockpiled Antivirals Tamiflu (Oseltamavir) and Relenza (Zanamivir) at or Nearing Expiration (7/2009)

Q-Based Solutions Inc. Marketing Unapproved/Unauthorized/Uncleared Products Relating to the H1N1 Flu Virus (7/2009)

MGS Representations Marketing Unapproved/Unauthorized/Uncleared Products Relating to the H1N1 Flu Virus (7/2009)

Early Communication about the Safety of Lantus (Insulin Glargine) (7/2009)

FDA Takes Action on Darvon and Other Pain Medications (7/2009)

Immunosuppressant Drugs Requiring Labeling Changes: Sirolimus (marketed as Rapamune), Cyclosporine (marketed as Sandimmune and generics), Cyclosporine modified (marketed as Neoral and generics), Mycophenolate mofetil (marketed as Cellcept and generics), and Mycophenolic acid (marketed as Myfortic) (7/2009)

Safety Labeling Changes Approved By the FDA – June 2009
These changes affect 31 drug products with safety label sections of: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

Class I Recall: Medtronic Inc., Kappa 600/700/900 Series of Pacemakers and Sigma 100/200/300 Series of Pacemakers (6/2009)

Levemir Insulin (Novo Nordisk): Vials Appear on the Market after being Stolen and Improperly Handled and Stored (6/2009)

Zicam Cold Remedy Nasal Gels and Swabs (6/2009)

Propylthiouracil Induces Liver Failure (6/2009)

Carico Brand Digoxin USP 0.25 mg and USP 0.125 mg (5/2009)

Fun Express Inc. recalls children's face paint (5/2009)

FDA Health Fraud Awareness Page - helps inform consumers of and raise awareness about potential health fraud (5/2009)

Personal Care Products Conducts Nationwide Recall of Non-Acetone Nail Polish Remover (4/2009)

Undeclared Sibutramine found in dietary supplements distributed by Universal ABC Beauty Supply International Inc. (4/2009)

ION Labs Inc. recalls Influend Cough and Cold Products (4/2009)

Caraco Pharmaceutical Laboratories issues nationwide recall of Digoxin tablets, all lots, due to size variability (4/2009)

FDA Receives a Permanent Injunction Barring Advent Pharmaceuticals and Neilgen Pharmaceuticals from Manufacturing and Distributing Unapproved Drugs (4/2009)

UPDATE: FDA Statement Genetech's Raptiva Recall - Effective June 6, 2009 Raptiva will no longer be available in the United States (4/2009)

Caraco Pharmaceutical Laboratories issues nationwide recall of Digoxin tablets, all lots, due to size variability (4/2009)

FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs (3/2009)

Class 1 Recall: Baxter Colleague Single and Triple Channel Volumetric Infusion Pump (3/2009)

Class 1 Recall: Shiley 3.0 PED Cuffless Pediatric Tracheostomy Tube by Covidien Inc (1/2009; updated 3/2009)

FDA Advisement: Transdermal Patches Overheating during MRI (3/2009)

Peanut Product Recalls: Salmonella Typhimurium (2/2009)

FDA and Roche Laboratories notify healthcare professionals of CellCept Medication Guide (2/2009)

Novartis Vaccine Recall: FLUVIRIN (Influenza Virus Vaccine) Luer-Lok pre-filled syringes (2/2009)

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Archive of Alerts & Recalls

For additional recall notices issued prior to 2009, 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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