Should you be in possession of a recalled pump, Sigma is requiring the return of the devices. For questions and return information please, contact the company at 1-866-482-2893, Monday through Friday, 8 AM though 5 PM (Eastern Time). Click here for more information.

November 11, 2010

Recall Notice: Triton Pole Mount Infusion Pump by WalkMed: Recall - Potential Door Open Alarm Problem

On October 8, 2010, WalkMed Infusion LLC. and the FDA notified healthcare professionals of a nationwide recall of the Triton Pole Mount Infusion Pump, serial numbers 001 through 500 and serial numbers TR1401 through TR 2559, manufactured and sold before June 2010. The issue stems from a problem with the latch alarm on the pump door which if gone unnoticed could potentially lead to an over infusion of medication to the patient. It is requested that consumers who have Triton Pole Mount Infusion Pumps which are being recalled should return the pump to the manufacturer. Click here for more information.

October 29, 2010

Recall Notice: Heparin Sodium (B. Braun): Recall - Trace Contaminant

On October 29, 2010, B. Braun Medical Inc. and FDA notified healthcare professionals of a nationwide recall of certain lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because testing indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010. Should you be in possession of this product discontinue use immediately. To identify Product lot numbers, expiration dates, and recall instructions please, reference the Recall Notice in the following link Click here for more information.

October 18, 2010

Recall Notice: CareFusion Corp. Issues Recall of Alaris PC Units (Model 8015) Due to Potential For Delay or Interruption of Therapy

On October 15, 2010, CareFusion Corporation issued a recall of its Alaris PC Units (Model 8015) manufactured between the time period of December 20, 2008 through September 8, 2009 and distributed from December 20, 2008 through June 28, 2010. The organization identified that under certain wireless network conditions, a communication error can occur which can lead to the freezing/interruption of the PC Unit screen and a subsequent delay in therapy. Should the communication error occur during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down resulting in a delay or interruption in therapy which could lead to serious injury or death. Any users experiencing this problem should remove the device from service and contact the CareFusion Recall Center immediately at 888.562.6018 or via email at SupportCenter@carefusion.com. Corrective action will require a hardware update to all affected units. Please also note that CareFusion does not require that the devices be returned. Click here for more information.

October 18, 2010

Recall Notice: Excelsior Medical Identifies Potential Loss of Sterility and Leaking in 5ml Fill in 6cc Prefilled Saline Flush Syringes

On October 15, 2010, Excelsior Medical issued a recall notice that several models of its Prefilled Saline Flush Syringes had the potential to leak and/or lose sterility. The recall pertains only to syringes with the following product code numbers: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. Please note that using syringes that have a sterility issue could result in systemic infection, which may lead to serious injury and/or death. Should you be in possession of any of these syringes, please discontinue use immediately and return them to your point of purchase. It is advised that healthcare professionals and patients report any adverse health events related to use of this product to the FDAÂ’s MedWatch Safety Information and Adverse Event Reporting System. Click here for more information.

September 27, 2010

Amgen Initiates Voluntary Nationwide Recall of Certain Lots of EPOGEN ® and PROCRIT ®

Amgen announced September 24, 2010 that certain lots of EPOGEN(R) and PROCRIT(R) (Epoetin alfa) vials are being voluntarily recalled from specialty distributors, wholesalers, pharmacies and healthcare providers as a precaution. The product that is being recalled may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product. The recall is being conducted in cooperation with the United States Food and Drug Administration. Evaluations by Amgen and Centocor Ortho Biotech Products, L.P. found a low potential to impact patients who may have received the affected product. The potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic and other vascular events (e.g., phlebitis), and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity. Adverse events related to EPOGEN should be reported to 1-800-77-AMGEN. Adverse events related to PROCRIT should be reported to 1-800-547-6446. Consumers with questions regarding this recall can contact Amgen at 1-800-77-AMGEN (open 24 hours per day, 7 days per week) or Centocor Ortho Biotech Products at 1-800-547-6446 (open 24 hours per day, 7 days per week). Click here for more information.

September 17, 2010

Valcyte (valganciclovir hydrochloride) Label Change: Possible overdose in pediatric patients

The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals of new pediatric dosing recommendations for Valcyte (valganciclovir hydrochloride) oral tablets and oral solution. This change is being made to prevent potential valganciclovir overdosing in children with low body weight, low body surface area, and below normal serum creatinine. The revised dosing recommendations are being updated to include an upper limit on the calculated creatinine clearance using the modified Schwartz formula, which is used to calculate the pediatric dose of Valcyte. Valganciclovir is an antiviral medication that can be effective for the prevention of cytomegalovirus (CMV) disease in children 4 months to 16 years of age who have undergone a kidney or heart transplant. Cytomegalovirus is a member of a group of herpes-type viruses that can cause disease in different parts of the body. Patients with weakened immune systems, such as organ transplant patients, are particularly susceptible to CMV infection and must take medications such as Valcyte to prevent the disease. Click here for more information.

September 15, 2010

BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall

Westmed, Inc. is initiating a nationwide recall of 24,384 units of BagEasy Manual Resuscitation Devices. Select lots of the BagEasy device have been found to have a potential for disconnection at the retention ring of the patient port manifold. Disconnection causes the unit to be inoperable, which potentially could result in treatment delays while another unit is obtained or technician switches to a different method of resuscitation. This recall is classified by the FDA as a Class I Recall. Consumers who have units from the identified lots of BagEasy manual resuscitation devices which are being recalled should stop using them and return the product to Westmed or their distributor. To obtain the full listing of part numbers and lot numbers, visit the FDA website (www.fda.gov) or contact 1-800-975-7987. Westmed voluntarily recalled these products after learning of units disconnecting at user facilities. The FDA has been apprised of this action. Westmed has become aware of a potential for disconnection at the patient port retention ring assembly of the BagEasy manual resuscitation device after receiving reports from three separate facilities regarding units disconnecting during setup or use. The healthcare providers obtained another unit and continued with setup or treatment. The BagEasy manual resuscitation device was distributed to other medical device distribution companies as well as directly to hospitals and other treatment facilities. It can be identified by product labeling that contains part and lot numbers. Westmed is notifying its distributors and customers by certified mail and direct contact by sales representatives and is arranging for return of all recalled products. Click here for more information.

September 10, 2010

Fresenius Urgent Recall for AC Power Cords

Fresenius Medical Care is initiating this recall for certain Fresenius devices that may have a defective plug, which is part of an AC power cord manufactured by Electri-Cord Manufacturing Company. This alert is being issued in response to a FDA alert regarding customer reports of sparking, charring and fires of similarly designed AC power cores in non-dialysis products manufactured by other companies. Fresenius is advising all customers to assess whether their devices have the affected Electri-Cord AC power cords and inspect the cord plugs for evidence of damage (charring, discoloration of the plastic, broken or loose prongs). The potential risks from power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires, which may be exacerbated in an oxygen rich environment. Depending on the device, therapy, and environment, these failures may lead to potential serious injury or death. Fresenius Medical Care NA has not received any reports of serious patient harm related to the situation. Click here for more information.

August 16, 2010

FDA Proposes Withdrawal of Low Blood Pressure Drug: Companies failed to provide evidence of clinical benefit of midodrine hydrochloride

The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done. Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options. The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies. To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a patient’s ability to perform life activities. Orthostatic hypotension is a condition in which patients are unable to maintain blood pressure in the upright position and, therefore, become dizzy or faint when they stand up. Generic versions of the drug are made by Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories. According to a database used by the FDA, about 100,000 patients in the United States filled prescriptions for brand or generic forms of midodrine in 2009. Access the FDA information at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm222580.htm

March 19, 2010

FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor* (simvastatin) and increased risk of muscle injury

The U.S. Food and Drug Administration (FDA) is informing the public about an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class. The muscle injury, also called myopathy, is a known side effect with all statin medications. Patients with myopathy generally have muscle pain, tenderness or weakness, and an elevation of a muscle enzyme in the blood (creatine kinase). The higher the dose of statin used, the greater the risk of developing myopathy. The risk of myopathy is also increased when simvastatin, especially at the higher doses, is used with certain drug. The most serious form of myopathy is called rhabdomyolysis. It occurs when a protein (myoglobin) is released as muscle fibers break down. Myoglobin can damage the kidneys. Patients with rhabdomyolysis may have dark or red urine and fatigue, in addition to their muscle symptoms. Damage to the kidneys from rhabdomyolysis can be so severe that patients may develop kidney failure, which can be fatal. Known risk factors for developing rhabdomyolysis include age (> 65 years), low thyroid hormone levels (hypothyroidism), and poor kidney function. Myopathy and rhabdomyolysis are listed as possible side effects in the simvastatin and other statin drug labels. For more information, visit the FDA website by clicking here.

March 2, 2010

Baxter HomeChoice Peritoneal Dialysis Cycler

Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has classified Baxter’s recent Urgent Product Recall regarding Increased Intraperitoneal Volume (IIPV), or overfill of the abdominal cavity, associated with HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall. This action has been classified as a Class I recall because of the risk of serious injury or patient death that could be associated with the use of this device. Over the last two years, Baxter has received serious injury reports and at least one patient death report associated with this issue. For more information, visit the FDA website by clicking here.

February 26, 2010

OneTouch SureStep Test Strips (LifeScan): Recall

LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL. If patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death. The eight lots of consumer OneTouch SureStep Test Strips being recalled are identified in the firm's press release. Lot numbers are located on the outer carton and test strip vial. LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010. It is important that patients with recalled test strips continue to test their blood glucose. Patients with access to a meter that does not use OneTouch SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives. If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they should contact their healthcare professional for further instructions because their glucose may be significantly higher. Read the complete MedWatch 2010 Safety summary, including a link to the firm's press release.

February 16, 2010

Drug Safety Communication : Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp

FDA and Amgen notified healthcare professionals and patients that all ESAs must be used under a REMS risk management program. As part of the risk management program, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving an ESA. Under the ESA APPRISE Oncology program, Amgen will ensure that only those hospitals and healthcare professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer. Amgen is also required to oversee and monitor the program to ensure that hospitals and healthcare professionals are fully compliant with all aspects of the program. FDA is requiring a REMS because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also show that ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions. Click here for more information including critical patient education on this topic.

January 28, 2010

RECALL: Edwards Lifesciences Aquarius Hemodialysis System

FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death. The recall includes model numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The product was distributed from July 12, 2007 through March 18, 2009. Baxter International, Inc. is the U.S. distributor of the Aquarius. The company notified its customers of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period. The company received reports of clinically significant fluid imbalance. When a certain level of fluid imbalance is detected the Aquarius will trigger an alarm. However, users are able to override this alarm and continue therapy. By repeatedly overriding the balance alarm without solving the issue, such as a closed clamp or kinked line, it is possible to remove too much fluid from or replace too much fluid to the patient. In extreme cases, this could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death. Public Contact: Baxter International, Inc. is the U.S. distributor of the Aquarius. For questions regarding the Aquarius, contact the Baxter Clinical Help Line at 1-888-736-2543. Click here for more information.

January 21, 2010

Nipro Medical Corporation Issues a Voluntary Recall of All GlucoPro Insulin Syringes

Nipro Medical Corporation, Miami FL, is initiating a nationwide recall of all GlucoPro Insulin Syringes (This does not include the GlucoPro syringe specific for use with the Amigo Insulin pump). These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection. Consumers who have GlucoPro Insulin Syringes should stop using and return them to point of sale for reimbursement. This recall includes all product codes and lot numbers with expiration dates before 2011-11 (Nov 1, 2011). The firm voluntarily recalled the products after learning of the possibility of needle detachment. FDA has been apprised of this action. No injuries have been reported to date. Product was distributed nationwide, including Puerto Rico. Company is notifying its distributors and customers by Fax and Email and is arranging for return of all recalled products. Consumers with questions may contact the company at 305.599.7174 x249. Click here for more information.

October 27, 2009

Accusure Insulin Syringes Qualitest Pharmaceuticals - Recall

Qualitest Pharmaceuticals and FDA notified healthcare professionals of a nationwide recall of Accusure Insulin Syringes. All syringes, regardless of lot number, are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection. Consumers who have any Accusure® Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. You can find the lot number on the white paper backing of each individual syringe. Click here for more information.

October 19, 2009

Dexferrum (iron dextran injection) - Labeling Change

American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum. Fatal reactions have followed the test dose of iron dextran injection, even in situations where the test dose was tolerated. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions. It is recommended that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions be readily available during Dexferrum administration. For more information, visit FDA Medwatch and American Regent.

October 12, 2009

Unomedical Issues Worldwide Recall of Certain Manual Pulmonary Resuscitators

Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR). The recall only impacts MPRs manufactured from July 2002 – March 2008 and matching the lot numbers listed on the following Unomedical web page: http://www.unomedical.com/?pageid=H3160. Unomedical is contacting customers to arrange for the return and credit of all MPR units subject to this recall by sending notification letters to distributors and customers. Customers with questions are urged to contact Unomedical at 1-800-634-6003.

October 3, 2009

Philips Issues Worldwide Recall of Select Heartstart Fr2+ Automated External Defibrillators

Philips announced today that it is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of a memory chip failure that may render the device inoperable. Only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) manufactured between May, 2007 and January, 2008 are included in the voluntary recall. For more information, visit http://www.fda.gov/Safety/Recalls/ucm185108.htm

October 1, 2009

New USP Standards for Heparin Products Will Result in Decreased Potency Adjustments may be needed to achieve desired anticoagulant effect in some patients *NEW*

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.

Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

September 16, 2009

LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc)

Audience: Emergency medical personnel, consumers. FDA notified healthcare professionals of a Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver therapy. Click here to find the serial numbers associated with this recall. An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death. Click here for more information about this recall.

September 3, 2009

Myfortic (mycophenolic acid)

Audience: Renal, cardiac, and hepatic transplantation healthcare professionals.
Novartis and FDA notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. The WARNINGS and ADVERSE REACTIONS sections of the Myfortic Prescribing Information have been revised to reflect this new safety information. PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of Myfortic therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk. Read the complete MedWatch Safety summmary (corrected) by clicking here.

August 26, 2009

Levemir Insulin (Novo Nordisk):Stolen vials still may be on market

FDA is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. FDA has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots. Read the complete MedWatch 2009 Safety summary including a link to the FDA News release and the original June 13,2009 alerts here.

August 24, 2009

Accusure Insulin Syringes [31G, 1/2 cc and 1 cc]

Audience: Patients with diabetes mellitus, pharmacists and diabetes healthcare professionals. Qualitest Pharmaceuticals and FDA notified patients and healthcare professionals of a voluntary nationwide recall of two lots of Accusure Insulin Syringes. The syringes in these lots have been found to have needles which can detach from the syringe. When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection. Consumers who have any recalled Accusure Insulin Syringes (31 G –Short Needle-either 1/2 cc or 1 cc, lot number 6JCB1 or lot number 7CPT1) should stop using them and contact Qualitest at 1-800-444-4011 for product replacement instructions. The lot number can be found on the white paper backing of each individual syringe. These recalled products were distributed from January 2007 through June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico). This information is posted here.

August 13, 2009

GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring Technology

Audience: Diabetes healthcare professionals, hospital risk managers, patients. FDA notified healthcare professionals of the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars. These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death.

GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars. Certain non-glucose sugars, including maltose, xylose, and galactose, are found in certain drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product. The FDA Public Health Notification provides a list of GDH-PQQ Glucose Test Strips and recommends that healthcare practitioners avoid using GDH-PQQ glucose test strips in healthcare facilities or take steps to never use them on patients receiving interfering substances.

May 6, 2009

CDC: Hepatitis B Vaccine

In December 2008, Merck communicated with CDC that it expected to deplete available adult and dialysis formulations of their hepatitis B vaccine, Recombivax HB® in the first quarter of 2009. Once depleted, these formulations will be unavailable for the remainder of 2009. Supply of GSK's Adult hepatitis B vaccine (Adult Engerix-B®) and Adult hepatitis A/hepatitis B combination vaccine (Twinrix®) is sufficient to meet demand for routine adult usage of this vaccine as well as CDC's ongoing High Risk Adult Hepatitis B Initiative. This information is posted at http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm

May 6, 2009

Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump

Audience: Diabetes healthcare professionals, patients. Disetronic Medical Systems Inc. and FDA notified healthcare professionals about a defect in the “up” and/or “down” buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of the “up” and/or “down” buttons. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. Users may contact ACCU-CHEK Spirit hotline noted in the Press Release for a replacement pump or for any other questions regarding this potential defect.

Read the complete MedWatch 2009 Safety summary, including a link to the firm's press release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Spirit

April 9, 2009

ZOLL AED Plus Defibrillator

ZOLL Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. On February 12 and March 31, 2009, the company sent their distributors and customers recall letters with recommendations and instructions for customers on specific steps to mitigate the identified problems with this device. Please visit http://www.fda.gov/cdrh/recalls/recall-021209b.html and http://www.zollaedplusbatteryhelp.com/

April 1, 2009

Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)

Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consumers with the recalled product should return these products to their pharmacy or place of purchase. Please visit http://www.fda.gov/oc/po/firmrecalls/caraco03_09.html

March 11, 2009

Baxter recalls Colleague Single and Triple Channel Volumetric Infusion Pumps

FDA notified healthcare professionals of a Class 1 Recall of model numbers Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163. These products were manufactured and distributed from February, 1997 through December, 2008. The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. Baxter sent a letter to all of its customers, which included advice and instructions to institutions using the infusion pumps.

Read the FDA notice at http://www.fda.gov/cdrh/recalls/recall-012309.html and also read Baxter's press release here.

February 12, 2009

CellCept (mycophenolate mofetil)

FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety information in language that patients can easily comprehend. FDA regulations require a pharmacist to distribute a copy of the Medication Guide to every patient who fills a CellCept prescription from this point forward. FDA has also required the introduction of a Medication Guide for mycophenolic acid, marketed as Myfortic by Novartis.

Read the complete MedWatch 2009 Safety summary including links to the Dear Healthcare Professional and Dear Pharmacist letters, the new Medication Guide and the current Prescribing Information, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#CellCept

December 2, 2008

Innohep (tinzaparin sodium injection)

FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by the study’s Data Safety Monitoring Committee because of an interim finding of an increase in all-cause mortality in patients who received Innohep. Information on the patients enrolled in the study, on the heparin used to manufacture Innohep, and on the heparin used in the study is still being collected and analyzed.

In July 2008, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age or older. FDA is concerned that the preliminary data from the IRIS study suggest that the increased risk of mortality is not limited only to patients 90 years of age or older. Therefore, FDA has requested that the company revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both. This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA anticipates submission of the final IRIS study report in January, 2009 and plans to complete its review soon thereafter. FDA will communicate its conclusions and any resulting recommendations to the public at that time. FDA will consider additional regulatory actions as appropriate after thorough review of all applicable data from the manufacturer of Innohep.

Read the complete MedWatch 2008 Safety summary, including a link to the FDA Communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep

November 6, 2008

ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)

Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death. These syringes are sold only by Wal-Mart or Sam's Club pharmacies under the ReliOn name. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes. FDA urges patients and health care professionals to check syringe packaging carefully for products with this lot number, not to use the product, and return the product to the pharmacy for replacement. The lot number can be found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe “peel-pack”.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html