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| Lists of Renal Related Articles from MedWatch | |
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RECALL NOTICES
Communication about HACH SteriChek “Sensitive” Total Chloramines and Residual Chlorine Reagent Strips that may have been shipped to your facility/office Posted 7/23/2008
MedWatch - 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product recalled: bacteria contamination
Sage Products informed healthcare professionals of the voluntary recall of limited lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation product. The product was recalled because certain lots were found positive for Burkholderia cepacia (B. cepacia). B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as a weakened immune system or chronic lung diseases, particularly cystic fibrosis (CF) may be more susceptible to infections with B. cepacia. This organism is a known cause of infections in hospitalized patients and its effects range from no symptoms to serious respiratory infections, especially in patients with CF. The product was distributed to U.S. hospitals and medical centers nationwide and was shipped between 4/28/08 and 6/19/08. Healthcare professionals should stop using the product and coordinate the return of the product with the manufacturer.
Read the complete MedWatch 2008 Safety Summary, including a link to the firm press release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Chlorhexidine Posted 7/1/2008
FDA MedWatch -Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula With Iron Powder- Product Recalled Because Of Oxidation
Abbott notified consumers and healthcare professionals of the recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder, a low-calcium and Vitamin D-free infant formula specifically designed for the nutritional support of infants and children with hypercalcemia. The product, distributed in the United States between 06/06/06 and 04/17/08, is being recalled because small amounts of air may have entered the can, resulting in product oxidation. Consumption of highly oxidized foods can cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Parents should contact their healthcare professional if they have any questions or concerns.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Calcilo Posted 6/2/2008
FDA MedWatch- Solodyn (minocycline HCl) Extended Release Tablets: Recall Of Certain Lots Because One Bottle Of Solodyn Contained Azasan
Medicis and FDA notified healthcare professionals of the recall of lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of Solodyn Extended Release Tablets. The product was recalled because one of the bottles contained Azasan (azathioprine tablets) 75mg instead of Solodyn 90mg Tablets. Azasan is an immunosuppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking Azasan instead of Solodyn presents a health hazard and safety risk to patients. Side effects associated with the use of Azasan, particularly in the elderly, include myelosuppression, infection, bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain are also common side effects. Additionally, unanticipated interactions with other drugs may also lead to serious adverse events. The recall is limited to the lots referenced above. Healthcare professionals are urged to check their inventory and pull the referenced lot numbers from their stock and make arrangements with the manufacturer to return the product.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Solodyn Posted 5/20/2008
FDA Heparin Recall
CMS Notification to All State Survey Agencies
and Dialysis Facilities
FDA Bulletin
Network Letter
Posted 5/12/2008
FDA MedWatch- Cardinal Health Alcohol-Free Mouth- Product Recalled Because Of the Presence Of Burkholderia Cepacia
Hydrox Labs issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash because the product was found to contain Burkholderia cepacia (B. cepacia). The affected product lot number is 26228. B. cepacia poses little medical risk to healthy individuals. However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with this organism. Consumers and facilities with the recalled alcohol-free mouthwash should stop using the product and contact Cardinal Health for instructions on how to return the product.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Cardinal POSTED 5/8/2008
FDA MedWatch- Digitek (digoxin tablets)-Class I Recall Because Tablets May Contain Twice The Approved Level Of Active Ingredient
Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Digitek POSTED 5/2/2008
FDA MedWatch - Heparin Sodium USP - Voluntary Nationwide Recall Because Two Lots Had Heparin-like Contaminant
Covidien notified healthcare professionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. See the manufacturer's press release for the list of specific lots of the product affected by the recall. Use of the recalled product should be discontinued immediately. Patients should contact their physician if they experience any problems associated with the use of the product.Read the complete MedWatch 2008 safety summary, including a link to the firm press release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#heparinsodium POSTED 4/2/2008
Letter from Network 13 - Updated March 2008 FDA Notice Braun Heparin Recall POSTED 3/24/2008
MedWatch - Medtronic Neuromodulation Implantable Infusion Pumps: Class I recall - Reports of inflammatory mass formations
FDA and Medtronic notified healthcare professionals of the Class 1 recall of Medtronic Neuromodulation Implantable Infusion Pumps, implantable devices for administering drugs to a specific site in the body to treat pain, spasticity and cancer. The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 28, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device. The letter described the problem, patient risks, patient management, recommendations and next steps. Medtronic’s representatives will complete a reply card to document their communication with each doctor regarding this recall, as well as asking the doctors to sign and return a reply card.
Read the complete MedWatch safety summary, including links to the Recall Notice and the "Dear Healthcare Professional" letter, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Neuromodulation POSTED 3/24/2008
Letter From Network 13 - Updated Heparin Recall Information Posted 3/3/2008
Memo from Network regarding the Updated FDA Alert: Heparin Recall POSTED 2/12/2008
FDA MedWatch - Heparin Sodium Injection - Serious Adverse Events Reported In Patients Receiving Bolus Doses Of Medication
http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2 POSTED 2/11/2008
FDA MedWatch- Medtronic Inc. SnychroMed EL Implantable Infusion Pump - Class I Recall
FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories. The models were recalled because there is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors manufactured before September 1999. If a pump motor stalls, drug delivery will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient's symptoms, and/or symptoms of drug under infusion or withdrawal. Healthcare professionals and patients with questions should contact the manufacturer.
Read the complete 2008 MedWatch Safety Summary including a link to the FDA Class I Recall Notice regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#SynchroMed POSTED 2/4/2008
FDA Notices - Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ml 10 and 30ml Multi-Dose Vials Posted 2/4/2008
Recall of Baxter heparin following reports of allergic-type reactions among dialysis and other patients in multiple states POSTED 1/21/2008 (New)
Network 13 Memo to facilities regarding Heparin Recall POSTED 1/21/2008 (New)
FDA MedWatch - Heparin Sodium Injection 1000 units/mL recalled due to multiple adverse reactions reported POSTED 1/21/2008 (New)
CMS - Survey & Certification letter 07-34 “Survey Guidance for a New Home Hemodialysis Water Treatment Device, the “NxStage PureFlow™ SL Water Purification System (PureFlow™)” regarding the use of a new water treatment system called PureFlow with the NxStage dialysis equipment.
Copy of the recall letter from NxStage sent to their customers about the leaking cartridges
Posted 9/5/2007 - UPDATED 9/6/2007
Baxter Healthcare Corp. Recalls Baxter COLLEAGUE And FLO-GARD Volumetric Infusion Pumps Because Of Falsification Of Service And Repair Data
Baxter Healthcare and FDA notified healthcare professionals and consumers of a Class I Recall of Baxter COLLEAGUE and FLO-GARD Volumetric Infusion Pumps, Model numbers 2M8151 and 2M8153, COLLEAGUE CX Volumetric Infusion Pumps, Model numbers 2M8161 and 2M8163, and FLO-GARD Volumetric Infusion Pumps Model numbers 2M8063 and 2M8064.
The products were recalled because the firm identified repair, inspection, test data sheets, which included electrical safety data for the pumps, that were falsified. As a result it is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them. This may result in over/under infusion, failure to detect an upstream or downstream occlusion, electrical shock hazard, failure to detect air in line and malfunctions where the pump will stop infusing and result in an interruption of therapy that can lead to death. Return the affected pumps to Baxter Healthcare for repeat inspections and servicing. COLLEAGUE and FLO-GARD customers with questions should contact Baxter Healthcare Corp. at 1-800-422-4770.
Read the completed MedWatch 2007 Safety Summary including a link to the Recall notice at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#pumps Updated 7/30/2007
Azathioprine [Roxane] tablets recalled due to packing mix-up with Methotrexate
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Roxane Laboratories and FDA notified pharmacists and other healthcare professionals of a nationwide recall of a single manufacturing lot of Azathioprine tablets, 50 mg (Lot 558470A, Exp Mar 2009) used to help prevent rejection in kidney transplant patients, and to manage severe rheumatoid arthritis. The recall was initiated due to concerns that bottles from this single lot # 558470A, labeled as Azathioprine may contain Methotrexate, 2.5 mg tablets. Information has been sent to pharmacists alerting them of the details pertaining to this recall. Pharmacists who may have dispensed Azathioprine tablets to patients from manufacturing lot 558470A are instructed to contact those patients to assure they did not inadvertently receive Methotrexate tablets.
Getting Drugs After the Transition Period
CMS - TRANSITION FACT SHEET:
http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=1817 POSTED 4/10/2006
Serious problem for ESRD patients' glucoses while on Icodextrin Extraneal dialysis solution, and the effects of falsely elevated glucoses because of interaction of maltose using some glucometers? The FDA page link is http://www.fda.gov/cder/consumerinfo/druginfo/extraneal.htm - see the special warning section.
POSTED 4/18/2003
US Food and Drug Administration - Class 1 Recall: Ortho-Clinical Diagnostics VITROS® Immunodiagnostic HBsAg Confirmatory Kit POSTED 1/10/2006