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Clinical - Recalls and Warnings
Teva (TEVA) Initiates Voluntary Nationwide Recall Of Seven Lots Of Amikacin Sulfate Injection USP 500mg/2 Ml (250 Mg/Ml) And 1 Gram/4 Ml (250 Mg/Ml) Vials Due To Potential Of Glass Particulate Matter 7/29/2016
Stryker (SYK) Recalling a Select Number of Reprocessed AngioDynamics (ANGO) Soft-VU Angio Caths 7/27/2016
Following Revelations of ‘Flawed Studies’ in Clinical Trials, EMA Recommends Suspending Drugs; Many of Which Belong to Novartis AG (NVS) and Teva (TEVA) 7/26/2016
Medtronic (MDT) Recalls Pacing Leads Due to Design Standards Blunder 7/21/2016
Employee Taken to Hospital After Genentech (RHHBY) Hazmat Spill in South San Francisco 7/18/2016
Indonesia Orders Overhaul Of Drug Agency After Fake Vaccine Scandal 7/15/2016
AB Science (AB.PA) Release: Action Plan Following Warning Letter Has Been Validated By FDA 7/14/2016
Sucampo (SCMP) Terminates Development of Cobiprostone Following Phase II Data 7/11/2016
NeoCoil Recalls Flex Speeder MRI Device Due to Burn Risk 7/7/2016
Medtronic (MDT) Warns on Wire Fracture Risk with Activa DBS Devices 7/5/2016
Trividia Health Initiates Voluntary Recall Of Certain Lots Of TRUEread, TRUEbalance, TRUEtrack & TRUEtest Blood Glucose Test Strips 6/29/2016
FDA Hits Medtronic (MDT)'s TYRX with Warning Over Anti-Bacterial Envelopes 6/23/2016
Stryker (SYK) Voluntary Recalls Select Target Nano Neuro Coils 6/21/2016
Johnson & Johnson (JNJ)'s Ethicon (JNJ) Recalls Physiomesh Flexible Composite Hernia Mesh 6/21/2016
Big Pharmas Like Cipla (CIPLA), Pfizer (PFE) Among the 200 Under Inspection for Poor Drugs 6/21/2016
Phalanx Labs Banned from Shipping Products to U.S. After Refusing Inspection 6/21/2016
Manufacturing Problems at Plant Disrupts Production of Some GlaxoSmithKline (GSK) Drugs 6/17/2016
Boston Scientific (BSX) Updates Warnings for Pelvic Mesh Products 6/15/2016
FDA Lifts Shipping Restrictions On Terumo’s Michigan Plant 6/13/2016
Teva (TEVA) Suspends Marketing for ZECUITY in the U.S. 6/13/2016
Embattled Theranos Catches a Break, Says Only 1% of Tests Have Been Voided or Corrected 6/7/2016
Zimmer Biomet Slapped with a FDA Warning Letter in May 6/6/2016
Medtronic (MDT) Recalls Midas Rex Sagittal Saws on Leaky Seals Risk 6/3/2016
Cardinal Health (CAH)'s Cordis (JNJ) Recalls Precise Pro RX Carotid Stent Over Separation Issues 6/1/2016
Bay Area's Intuitive Surgical (ISRG) Warns on Embolism Risk with Da Vinci Xi in Heart Procedures 6/1/2016
FDA Slaps Class 1 Tag on Medtronic (MDT)'s Capnostream Battery Pack Recall 5/31/2016
Bay Area's Intuitive Surgical (ISRG) Accused of Hiding More than 700 Injury Claims Involving Its Da Vinci Surgical Robot, Says Insurer 5/27/2016
Abbott (ABT) Warns on Topera Catheter Spline Fracture Risk 5/24/2016
French Authorties Blame Both Biotrial and Bial Over Fatal Drug Trial 5/24/2016
FDA Slaps Warning on Eclipse Aesthetics' Micropen Personal Dermabrasion Device 5/23/2016
Europe Lifts Warning on Pfizer (PFE)'s Smoking Cessation Drug Champix 5/23/2016
Embattled Theranos Tosses Out Two Years of Edison Blood Test Results 5/20/2016
FDA Warns Against Off-Label Use of Johnson & Johnson (JNJ)'s Nizoral Tablets to Treat Skin And Nail Infections, Linked to Patient Death 5/20/2016
Failure To Report Infuse Data Was Unintentional, Says Medtronic (MDT) 5/19/2016
Popular Pain Med Lyrica Linked To Major Birth Defects, Lausanne University Hospital Study 5/19/2016
FDA Lifts Recall On Custom Ultrasonics' Endoscope Reprocessors 5/17/2016
Sanofi (SNY) Recalls Some Batches of Combiflam in India 5/12/2016
FDA Warns of Potential Safety Risk for Eli Lilly (LLY) Antipsychotic Drug Zyprexa 5/11/2016
PharMEDium Issues Voluntary Nationwide Recall Sterile Preparations Compounded With A Single Recalled Lot Of Fresenius Kabi Sensorcaine-MPF (Bupivacaine Hcl) Due To The Presence Of Glass Particulate Matter 5/9/2016
Why B.Braun Medical's Latest Recall is a Serious One 5/6/2016
Otsuka America Pharma's Abilify Can Cause Urges to Gamble, Eat, Shop, Have Sex: FDA 5/5/2016
Cook Medical Recalls Catheters with Beacon Tip Technology 5/4/2016
Claims Against Johnson & Johnson (JNJ)'s Talcum Powder Gets Alarming 5/3/2016
Federal Health Regulators Release Lightly Redacted Theranos Report with More Details 5/2/2016
Merit Medical (MMSI) Looks to Take Advantage of Rival Cook Medical's Catheter Recall 5/2/2016
Halyard Health Rejects 60 Minutes Allegations Regarding Safety of Surgical Gowns 5/2/2016
Heritage Pharmaceuticals Issues Product Safety Warning Due To Reported Sales Of Counterfeit Drug Product Labeled As BiCNU (Carmustine For Injection) 100mg Outside Of The United States 4/29/2016
Study Reveals More Than One-Third of Hip Implants Made by Johnson & Johnson (JNJ)'s DePuy Synthes Were the Wrong Size 4/29/2016
Fresenius Kabi AG Issues Voluntary Nationwide Recall Of Sensorcaine-MPF (Bupivacaine HCl) Injection, USP Due To The Presence Of Particulate Matter Characterized As Glass 4/26/2016
Good News for NeuroDerm (NDRM) as the FDA Removes Import Alert of Infusion Pumps Used in ND0612 Clinical Trials 4/22/2016
Pharmakon Pharmaceuticals Issues Voluntary Nationwide Recall Of All Sterile Compounded Products Due To FDA Concern Of Lack Of Sterility Assurance 4/20/2016
How Olympus (OCPNF)' Superbug Problem Just Got Worse 4/19/2016
German Authorities Accuse India's Alkem Laboratories of Fudging Data in Clinical Trials 4/18/2016
Minnesota Senator Pushes FDA, Medtronic (MDT) for Infuse Study Details 4/13/2016
How Medtronic (MDT) Misplaced 1,000 Negative Infuse Reports 4/12/2016
Boston Scientific (BSX) Issues Voluntary Recall of Fetch 2 Aspiration Catheter 4/11/2016
Vascular Solutions (VASC) Recalls Guardian II Hemostasis Valves 4/11/2016
Medtronic (MDT) Disputes Star Tribune's Infuse Story 4/11/2016
Boston Scientific (BSX)'s Watchman FLX Pulled From European Shelves Over Embolism Concerns 4/5/2016
Federal Report Reveals Theranos Devices Often Failed Accuracy Requirements 4/4/2016
FDA Probes Allegations of Counterfeit Boston Scientific (BSX) Mesh 4/4/2016
1,000+ Women are Suing Johnson & Johnson (JNJ) for Allegedly Covering Up Baby Powder Cancer Risk for Decades 4/1/2016
FDA Hits Cook Medical's Central Venous Cath Recall with a Class 1 Tag 3/31/2016
FDA Warns DNA4Life, DNA-CardioCheck and Interleukin Genetics (ILGN) for DTC Genetic Tests 3/29/2016
Health Canada Release: Information Update - Jamp-Hydrocortisone Cream 1% Recalled Due To Contamination With Bacteria, Yeast And Mould 3/25/2016
FDA Slaps Terumo with Warning Letter Over Destination Guiding Vascular Sheaths 3/25/2016
FDA Announces Enhanced Warnings For Immediate-Release Opioid Pain Medications Related To Risks Of Misuse, Abuse, Addiction, Overdose And Death 3/23/2016
$90 Million China Vaccine Scandal Prompts Angry Backlash From Parents And Doctors 3/22/2016
FDA Slaps a Class I Recall on Verathon's Video Laryngoscope 3/21/2016
Physio-Control Recalls Certain Lots of Its AED Electrodes 3/18/2016
FDA Warns India's Emcure Pharma for Repeatedly Fudging Data at Plant 3/17/2016
Abbott (ABT) Voluntarily Recalls MitraClip System 3/16/2016
Gilead (GILD)'s Zydelig Under Review in Europe Following Reported Deaths, Side Effects When Combined With Other Drugs 3/15/2016
Pfizer (PFE), Abbott (ABT) to Stop Selling Cough Syrups After India Ban 3/15/2016
Government Scientists Raise Questions About the Potential Risks of Abbott (ABT)'s Dissolving Stent 3/15/2016
Teleflex Incorporated (TFX) Recalls ARROW International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits 3/11/2016
Maharashtra FDA to Test Johnson & Johnson (JNJ) Baby Powder for Cancer-Causing Substances After $75 Million U.S Verdict 3/10/2016
FDA Warns Repro-Med Systems (REPR) on Freedom Infusion Set Issues 3/10/2016
Teva (TEVA) Initiates Voluntary Nationwide Recall Of One Lot Of Amikacin Sulfate Injection USP 1 Gram/4ml (250 Mg/Ml) Vials Due To Glass Particulate Matter 3/10/2016
Report Questions if Theranos Provided Blood Tests to 81 Patients Despite Quality Assurance Issues 3/8/2016
FDA Expands Draeger's Ventillator Recall to Include Power Supply Batteries 3/4/2016
How Olympus (OCPNF)' Scope Problems Got So Unbelievably Bad 3/3/2016
FDA Slaps ReWalk (RWLK) with Warning Letter for Failure to Submit Post-Market Surveillance Report for Exoskeleton 3/3/2016
FDA Wants Bayer (BAY) to Do More Studies on Essure Birth Control Device 3/1/2016
Abbott (ABT) Warns Surgeons on Potential Issue with Mitraclip Heart Implant 2/26/2016
Cook Medical Expanded Its Class I Recall for Beacon Tip Angiographic Catheters 2/26/2016
Hospital Warns 213 Patients May Have Been Exposed To Hepatitis, HIV Due To Tampering of Drugs By Ex-Employee 2/26/2016
More Bad News for Theranos as Rice University Study Questions the Accuracy of Fingerprick Blood Testing 2/25/2016
Consumers are Uneasy Using Johnson & Johnson (JNJ) Products After Firm is Ordered to Pay $75 Million for Talc Powder Cancer Case 2/25/2016
UK Firm Bedfont Scientific Banned from Shipping Medical Devices to U.S. 2/24/2016
Sure Genomics Gets FDA Letter for Marketing Diagnostic Without Approval 2/19/2016
303 Fetal Deaths May be Linked to Bayer HealthCare (BAY)'s Essure; Congressman Raises New Concerns About Contraceptive Device 2/18/2016
Zimmer (ZMH) Biomet Warns of Packaging Issue with Hip, Knee and Shoulder Implants 2/18/2016
Theranos Files Plans with U.S. Regulators to Fix All Serious Deficiencies at Bay Area Lab 2/16/2016
Pfizer (PFE) Recalls Advil Liquid Products for Children and Infants 2/16/2016
Cook Medical Issues Global Recall of Select Lots of Central Venous Catheters and Pressure Monitoring Sets and Trays 2/11/2016
Ex-FDAAdvisoryCommittee.com Head Accused of Conspiring to Suppress Information About Harmful Effects of Johnson & Johnson (JNJ) Antibiotic 2/11/2016
Dräger Slapped With Another Class I Recall 2/9/2016
Royal Philips Electronics N.V. (PHG) Issues a Set of Urgent Safety Notice for Allura Systems 2/2/2016
Johnson & Johnson (JNJ)'s Ethicon (JNJ) Recalls Gynecare Thermachoice III Cath on Shelf Life Issues 2/2/2016
Aurobindo Pharma (AUROBINDOP.BO) Shares Fall On FDA Concerns 2/1/2016
FDA Discovers Wockhardt (WOCKHARDT.BO) Hid Failed Tests and Deleted Data at Indian Plant 2/1/2016
Federal Regulators Find Conditions at Theranos Lab That Pose "Immediate Jeopardy to Health" 1/29/2016
Feds Find "Serious Deficiencies" at Theranos Lab 1/26/2016
FDA Slaps St. Jude Medical (STJ)'s Optisure Dual Coil Defibrillation Leads with a Class I Recall 1/25/2016
Pfizer (PFE) Quietly Recalls Three Lots of Blockbuster Drug Lyrica 1/25/2016
Fourth Patient Treated with Carmat (ALCAR.PA)'s Artificial Heart Dies 1/22/2016
Off Label Use of Roche (RHHBY)’s Avastin in India Puts 15 in the Hospital, Prompts Officials to Halt Using the Drug 1/21/2016
Man in Coma Dies After Bial's Botched Drug Trial in France, Five Remain Hospitalized 1/19/2016
FDA Slaps BrainLAB AG's Cranial IGS System with a Class I Recall 1/18/2016
Former C.R. Bard Employee Says 510(k) Process May Be to Blame for Vena Cava Filter Deaths 1/14/2016
FDA Tags Stryker's Pleural Drainage Device Recall a Class I 1/13/2016
Overdose Fears Spark Recall Of Children's Cough Syrup 1/13/2016
Ex-GlaxoSmithKline (GSK) Biostatistician Sues, Claims He was Let Go Over Nicoderm Studies 1/13/2016
Why Merck & Co. (MRK) May Find Twitter an Unfriendly Environment to Be In 1/11/2016
Regeneron (REGN) Investors Get Jitters From False Praluent Data 1/8/2016
PA Rep Wants the FDA to Launch Criminal Probe into Morcellator Deaths 1/7/2016
Cadila Healthcare Shares Plunge After FDA Warning 12/31/2015
Boston Scientific (BSX) Recalls Chariot Guiding Sheaths After Pieces Broke Off in Patients 12/10/2015
Defective Device Forces Regulators to Take a Hard Look at Bayer (BAY)'s Xarelto Trial 12/9/2015
Olympus (OCPNF) Recalls Select EndoEye HD II Endoscopes Over Heat Issue 12/9/2015
Chinese Customs Officers Seize 120,000 Fake Face Masks Supposedly Made By 3M Company (MMM) 12/9/2015
FDA Report Says Pfizer (PFE) Chinese Plant Hid Failures, Used Expired Ingredients 12/8/2015
Insulet (PODD) Voluntarily Recalls Omnipods on Needle Deployment Issue 12/4/2015
FDA Slaps a Class II Recall on Three of Royal Philips Electronics N.V. (PHG)'s Allura Xper Vascular X-ray Systems 12/3/2015
Medtronic (MDT) Recalls Nearly 97,000 Insync III Pacemakers Due to Battery Issue 12/2/2015
Boston Scientific (BSX)'s Artery-Clearing Tools Recalled After Patient Death 11/30/2015
Boston Scientific (BSX) Recalls Atherectomy Components 11/18/2015
AngioDynamics (ANGO) Announces Resolution of FDA Warning Letter 11/17/2015
FDA Orders Recall of All Custom Ultrasonics' Endoscope Reprocessors 11/16/2015
About One in Five Patients Taking AstraZeneca PLC (AZN)'s Brilinta Stopped Due to Side Effects 11/13/2015
Gilead (GILD), Sanofi (SNY) Scored Lowest in Disclosing Clinical Trial Data While GlaxoSmithKline (GSK), Johnson & Johnson (JNJ) and Pfizer (PFE) Ranked Highest 11/13/2015
Momenta (MNTA) Puts a Temporary Hold on Enrollment in Phase II Necuparanib Study to Discuss Specific Toxicities 11/13/2015
Novartis AG (NVS)'s Japanese Unit in Trouble Again for Failing to Report Drug Side Effects on Time 11/12/2015
FDA Sends Warning Letter to DNA4Life Over Consumer Gene Tests 11/10/2015
Dr. Reddy's Laboratories Ltd. (RDY) Drops the Most in 11 Years on FDA Warning 11/9/2015
Gilead (GILD)'s Blockbuster Sovaldi Linked to Slower Heartbeats and Puts Patients at Risk of Passing Out 11/6/2015
Quest Medical Issues Recall for Open Heart Surgery Drug Delivery Devices 11/2/2015
FDA Requests Aros Surgical to Cease Sales of Its Surgical Sutures, Micro Anastomosis Clamps 10/30/2015
Sanofi (SNY) May Suffer a $109 Million Hit from Injector Recall 10/29/2015
FDA Reports From Lab Visits Highlight Problems at Theranos 10/29/2015
Walgreens Halts Expansion of Theranos Blood Testing Centers Until Questions Gets Answered 10/27/2015
AbbVie (ABBV)'s Pain is Gilead (GILD)'s Gain After FDA Slaps Warning on AbbVie’s Hepatitis Drugs 10/26/2015
European Medicines Agency Recommends Suspension Of Medtronic (MDT)'s Implant Inductos 10/23/2015
FDA Release: Downing Labs Issues Voluntary Nationwide Recall Of All Sterile Compounded Products Due To Lack Of Sterility Assurance 10/21/2015
Theranos Refutes Scathing Wall Street Journal About its Blood Testing Technology 10/16/2015
Cook Medical Expands Recall of Select Sizes of Beacon Tip Angiographic Catheters 10/12/2015
Sientra (SIEN) Temporarily Halts U.S. Sale of Devices Manufactured by Silimed 10/12/2015
Needle Maker International Medical Development Hit with a FDA Warning 10/8/2015
Death Forces FDA to Place Clinical Hold on Advaxis (ADXS) Cancer Drug 10/8/2015
Monsanto  (MON) Nudges Eight Scientists to Write Pro-GMO Papers 10/6/2015
FDA Slaps St. Jude Medical (STJ) with Warning Letter for Atlanta Facility 10/5/2015
Women Ask the FDA to Withdraw Bayer (BAY)'s Controversial Contraceptive Essure 9/25/2015
FDA Berates Sironis for Running Unapproved Trial 9/25/2015
FDA Hits Pearson With Warning Over ADHD Device Claims 9/25/2015
Pathway Genomics's Cancer Blood Test May Harm Public, FDA Says 9/25/2015
Sale of Silimed's Breast Implants Suspended Amid Contamination Fears 9/24/2015
Complaints for Bayer AG (BAYZF)'s Sterility Device Spike Nearly 1,400% in Three Years 9/22/2015
Many "All-Natural" Dietary Supplements Contain Potent Drugs, Harvard University Professor Reveals 9/22/2015
Pfizer (PFE) Weighing FDA Request to Change Zoloft's Warnings 9/18/2015
Sprout’s Female Libido Drug Brings Up More FDA Dissent and Men-Oriented Testing 9/17/2015
Abbott Healthcare Challenges Cough Syrup Complaint 9/14/2015
Faulty Batteries Prompts Recall of Two Draeger Medical, Inc. Ventilators Used in Pediatrics 9/9/2015
Teleflex Incorporated (TFX) Announces Worldwide Voluntary Recall Of HUDSON RCI SHERIDAN SHER-I-BRONCH Endobronchial Tube 9/8/2015
Medtronic (MDT)'s Breathing Device Recalled for Second Time in a Year 9/3/2015
FDA Warns Merck & Co. (MRK), AstraZeneca PLC (AZN) and Boehringer Ingelheim About Joint Pain With Diabetes Drugs 9/2/2015
Insulet (PODD) Recalls More Than 400,000 OmniPods 8/31/2015
ConforMIS Initiates Voluntary Recall of iUni, iDuo and iTotal Systems 8/31/2015
FDA Slaps CareFusion, Elite Biomed Class I Recalls for Drug Pumps 8/28/2015
Teleflex Medical Slammed With Another Class 1 Recall 8/27/2015
Allergan (AGN) Issues Voluntary Nationwide Recall In The U.S. Of Specific Lots Of REFRESH Lacri-Lube, REFRESH P.M. , FML (fluorometholone ophthalmic ointment) 0.1%, And Blephamide (sulfacetamide Sodium And Prednisolone Acetate Ophthalmic Ointment, USP) 10%/0.2% For Particulate Matter 8/24/2015
Scope Maker Olympus (OCPNF) Investigates SoCal Infections, Denies FDA Violation 8/21/2015
FDA Slaps Warning on Transdermal Cap Over a Handful of Operational Issues 8/20/2015
Merck & Co. (MRK) Recalls Temodar And Temozolomide Bottles With Cracked Caps Due To Failure To Meet Child-Resistant Closure Requirement 8/19/2015
FDA Issues Recall After Western/Scott Fetzer's Explosive Oxygen Unit Killed One Person and Injured Another 8/19/2015
Blackberry Infusion Pump "Hack" Was A Sham, Says Hospira 8/17/2015
GlaxoSmithKline (GSK) Shuts Down NC Plant After Discovering Legionnaire’s Bacteria 8/17/2015
Biogen (BIIB) Sinks Some More After Doctors Fear More Brain Infections Will Occur in Patients Taking Drugs Like Tecfidera 8/10/2015
Medtronic (MDT) Recalls Loading System for EnVeo R Loading System 8/7/2015
Hospira's Hospital Drug Pump Can Be Hacked Through Network, FDA Warns 8/3/2015
Unichem Pharmaceuticals (USA), Inc. Issues A Voluntary Nationwide Recall Of Hydrochlorothiazide Tablets Due To The Potential Presence Of Foreign Tablets 7/31/2015
Medtronic (MDT) Warns Customers on Potential Minimed Pump Glitch 7/29/2015
FDA Slaps Alphatec Spine With Warning Letter Over SoCal Plant 7/24/2015
Teva Parenteral Medicines (TEVA) Initiates Voluntary Nationwide Recall Of Select Lots Of Adrucil (Fluorouracil Injection, USP) 5 G/100 Ml (50 Mg/Ml) Due To Particulate Matter 7/24/2015
C. R. Bard, Inc. (BCR) Discloses FDA Warning Letter Over IVC Filter Retrievers 7/22/2015
Biogen (BIIB) Reports Second Non-Fatal Tecfidera PML Case 7/20/2015
Why Medtronic (MDT) Is Facing a Major Tracheostomy Tube Recall 7/16/2015
Software Glitch Prompts a Class I Recall of Hamilton Medical Ventilator 7/15/2015
AB Science (AB.PA) Studies Banned in France Due to Side Effects 7/9/2015
Indian CRO Quality Questioned, As Quest Life Sciences Warned by WHO for HIV Trial Fraud 7/9/2015
Teleflex Incorporated (TFX) Recalling Its Hudson RCI Manual Resuscitator 7/7/2015
Novartis AG (NVS) Researchers ID Possible Link Between GlaxoSmithKline (GSK) Flu Vaccine, Narcolepsy 7/6/2015
MAQUET Recalls Flow-i Anesthesia Systems 7/2/2015
Zimmer (ZMH) Slammed With a Serious Hip Replacement Part Recall 7/1/2015
Health Canada Release: Advisory - Two Lots Of Sanofi-Aventis (Canada)'s Allerject (0.15 Mg / 0.15ml Auto-Injector) For Use In Children Recalled Due To Manufacturing Defect 6/15/2015
Pfizer (PFE) Report Shows Scientist Warned Execs About Zoloft Risks Last Year 6/10/2015
FDA Shuts Down NIH Pharma Lab After Finding Contamination 6/9/2015
New Book Claims Grunenthal GmbH Knew About Thalidomide Risk Six Months Before Drug Was Pulled 5/26/2015
Dosing Errors With Cubist (MRK) Antibiotic Prompt FDA Warning 5/22/2015
New FDA Warning Impacts Diabetes Drugs Made by AstraZeneca PLC (AZN), Johnson & Johnson (JNJ) and Eli Lilly (LLY) 5/22/2015



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