Acetadote (acetylcysteine) Injection: Recall - Particulate Matter Found in a Small Number of Vials(2)January 3, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments
6 lots of Acetadote is being recalled as a precautionary measure based on observed particulate matter found in a small number of vials.
Quality control issues involving Smith & Nephew’s ceramic acetabular hip implants have resulted in a warning letter.
Despite claims by the FDA and Centers for Medicare & Medicaid Services (CMS) that parallel review could expedite marketing of new devices, industry fears the opposite could happen, depending on how the program is implemented.
Arrow Intra-Aortic Balloon (IAB) Catheter Products: Class 1 Recall - Catheters Can Become Stuck in the SheathDecember 29, 2010 11:31 am | by U.S. Food & Drug Administration | News | Comments
Arrow Intra-Aortic Balloon (IAB) catheters can become stuck in the sheath and potential to cause delay in therapy, bleeding or arterial injury.
Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials - Recall Due to Particulates in Some VialsDecember 29, 2010 4:31 am | by U.S. Food & Drug Administration | News | Comments
Nationwide recall initiated December 23 due to some vials of these lots contain particulates.
Federal Register: Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or NV Consumer Repre...December 28, 2010 6:34 am | by U.S. Food & Drug Administration | News | Comments
The FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing.
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third Party Review Program...(2)December 28, 2010 6:31 am | by U.S. Food & Drug Administration | News | Comments
Section 210 of the FDAMA established section 523 of the FD&C Act (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket notifications (510(k)s). Participation in this third-party review program by...
Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingDecember 27, 2010 4:30 am | by U.S. Food & Drug Administration | News | Comments
On January 25, 2011, the committee will discuss and make recommendations regarding regulatory classification of Automated External Defibrillators to either reconfirm to class III (subject to premarket approval application (PMA)) or reclassify to class...
Product marketed as a dietary supplement contains sibutramine, a controlled substance known to substantially increase blood pressure and/or pulse rate, and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Product marketed as dietary supplement contains undeclared analogue of sildenafil, a drug which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
Questions and answers about Abbott Diabetes Care to recall 359 different lots of glucose test strips
The U.S. Food and Drug Administration today announced the agency is working with Abbott Diabetes Care to recall 359 different lots of glucose test strips
Falsely low blood glucose results can lead patients to try to raise their blood glucose when it is unnecessary, or to fail to treat elevated blood glucose due to a falsely low reading.
Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices: Class I RecallDecember 21, 2010 9:30 am | by U.S. Food & Drug Administration | News | Comments
Use of the recalled product has led to removal of greater amounts of red blood cells than intended, resulting in hemodilution.
Federal Register: Defense Advanced Research Projects Agency and Food and Drug Administration Expanding In Vivo Biomarker Detection Devices Workshop(2)December 20, 2010 3:31 am | by U.S. Food & Drug Administration | News | Comments
The FDA is announcing the following public workshop cosponsored with the Defense Advanced Research Projects Agency (DARPA): Expanding In Vivo Biomarker Detection Devices Workshop.
FDA recommending removing the breast cancer indication for Avastin because the drug has not been shown to be safe and effective for that use.
FDA Safety Notification: Risk of Eye and Skin Injuries from High-powered, Hand-held Lasers Used for Pointing or EntertainmentDecember 16, 2010 5:30 am | by U.S. Food & Drug Administration | News | Comments
The FDA is alerting consumers about the risk of eye and skin injuries from exposure to high-powered laser pointers. FDA regulations limit the energy output of hand-held laser pointers to 5 milliwatts (mW).
Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, Rolaids Multi-Symptom plus Anti-Gas Softchews: Recall - Foreign Materials in ProductsDecember 14, 2010 9:31 am | by U.S. Food & Drug Administration | News | Comments
Reports of foreign materials in the product, including metal and wood particles.
Product marketed as dietary supplement contains undeclared Sulfoaidenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
Federal Register: Medical Device User Fee Program; Meetings on Reauthorization; Request for Notification of Patient and Consumer Advocacy Group Intention to ParticipateDecember 13, 2010 4:32 am | by U.S. Food & Drug Administration | News | Comments
The FDA is issuing this notice to request that patient and consumer advocacy groups notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Medical Device User Fee Amendments of 2007 (MDUFA)...
Cold decongestant tablets (containing Acetaminophen, Phenylephrine, and Chlorpheniramine Maleate) were mislabeled as containing only Guaifenesin tablets.
The FDA’s Dental Products Panel will be asked this week to consider what scientific methodology is needed to determine unsafe levels of dental amalgam and mercury, especially for children and other vulnerable patients.
As Johnson & Johnson (J&J) subsidiary Ethicon Endo-Surgery prepares to defend its computer-assisted personalized sedation system before an independent advisory panel convened by FDA Commissioner Margaret Hamburg, CDRH is finally explaining why it rejected the Sedasys device in the...
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Mid-shaft joint failures occuring in some catheters.