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Clinical - Recalls and Warnings (World)
UK Warns About Alarm Failure for Roche (RHHBY)’s Accu-Check Insight Insulin Pumps 9/21/2017
Medtronic (MDT) Recalls Defective Diabetes Infusion Sets 9/11/2017
Royal Philips Electronics N.V. (PHG)'s Spectranetics (SPNC) Recalls Bridge Occlusion Balloon 8/31/2017
LivaNova (LIVN) Plant Linked to Heart Surgery Infections From Contaminated Medical Devices 7/14/2017
Health Canada Release: Advisory - Bayer (BAY) Expands Recall Of RestoraLAX, Sold Nationwide, Due To Potential Choking Hazard 7/10/2017
Medtronic (MDT) Recalls Kyphon Directional Bone Void Filler 7/10/2017
Liver Safety Issues Lead The EMA To Restrict Biogen (BIIB)'s MS Drug 7/10/2017
Endo Pharma (ENDP) Caves To The FDA, Agrees To Yank Opana ER From Market 7/7/2017
Novo Nordisk A/S (NVO) Warns of Possible Cracks in Novopen Echo Insulin Pen Devices 7/6/2017
Bayer (BAY) And Health Canada Release: Advisory - RestoraLAX 45 + 10 Value Pack Sold At Costco Canada Recalled Due To Potential Choking Hazard 7/5/2017
FDA Lifts Warning on Zimmer Biomet's China Plant 6/13/2017
Hundreds of Patient Deaths Linked to Roche (RHHBY)'s RA Drug Actemra 6/12/2017
Health Canada Release: Advisory - Multiple Unauthorized L-Tryptophan And Lithium Orotate Products Sold On Amazon.Ca May Pose Serious Health Risks 5/31/2017
Roche (RHHBY)'s New MS Drug Linked to Deadly Brain Infection 5/30/2017
FDA Slaps Class I Recall Tag on Royal Philips Electronics N.V. (PHG) Respironics V60 Ventilator 5/23/2017
FDA Slaps a Class I Tag on Medtronic (MDT)'s HVAD Splice Kit Recall 5/5/2017
Deaths Prompt Medtronic (MDT) to Update NavLock Tracker Device Label 5/4/2017
Medtronic (MDT)'s Newport Medical Recalls Ventilators Over Software Issues That Could Lead to Unexpected Shutdowns 5/4/2017
Abbott (ABT), Medtronic (MDT) to Withdraw Stents From Indian Market 4/25/2017
Up to 4,100 Children Victims of Sanofi (SNY)'s Epilepsy Drug, Says French Regulator 4/21/2017
FDA Slaps a Class I Tag on Medtronic (MDT)'s HVAD Recall 4/19/2017
Mylan (MYL)'s Shares Drop After FDA Lashes Out at Drugmaker for Drug Quality Control at HIV Drug Facility 4/12/2017
GlaxoSmithKline (GSK) Is Voluntarily Recalling 593,000 Ventolin Asthma Inhalers 4/5/2017
Royal Philips Electronics N.V. (PHG)'s HeartStart MRx Recall Is Class I, Says the FDA 3/27/2017
Mylan (MYL) Recalls 81,000 EpiPens Overseas After Reports of Failure 3/23/2017
Medtronic (MDT) Recalls Unused StrataMR Valves and Shunts 3/21/2017
FDA Issues Serious Warning on Allergan (AGN)'s IBS Drug Viberzi 3/17/2017
FDA Updates Class I Recall for Medtronic (MDT)’s SynchroMed Drug Pumps 3/15/2017
FDA Looks to Block Chinese Surgical Drape Maker Hubei Hongkang Protective Products Over Failed Inspection 2/16/2017
CDRH Sending Warning Letters to 3 Foreign Medical Device Manufacturers 2/8/2017
FDA Lashes Out at Jazz Pharma (JAZZ) CMO for Continued Regulatory Violations 1/30/2017
FDA Confirms St. Jude Medical (STJ) Heart Devices Can be Hacked 1/10/2017
FDA Issues Warning Letter To Wockhardt (WOCKHARDT.BO)’s Ankleshwar Plant 1/9/2017
3 Fires Linked to Medtronic (MDT)'s Bellco Formula Dialysis Device 11/29/2016
Vistin Pharma: Metformin Production Temporarily Halted Due to Unscheduled Maintenance Stop 11/18/2016
Sanofi Pasteur (SASY.PA) Abandons Bladder Cancer Drug 11/18/2016
Smith & Nephew plc (SNN) Recalls Modular SMF, Modular Redapt Hip Implants 11/17/2016
More Deaths Linked to Medtronic (MDT) Infusion Pump 11/2/2016
Boston Scientific (BSX) Hits the Pause Button on Next-Generation Lotus Edge Replacement Heart Valve in Europe 11/1/2016
FDA Posts Another Recall for Medtronic (MDT)-HeartWare (HTWR)'s HVAD Over Issues With Loose Power Connectors 10/31/2016
GlaxoSmithKline (GSK) Yanks HPV Vaccine From U.S. Market 10/25/2016
Teva (TEVA) Rallies Despite FDA Warning Letter 10/21/2016
FDA Panel Expresses Concerns Over Allergan (AGN)-Serenity Drug for Nighttime Urination 10/18/2016
Medtronic (MDT) Issues Yet Another Recall for Pipeline Device 10/17/2016
Medtronic (MDT) Calls Link to Faulty St. Jude Medical (STJ)'s Batteries Misleading, 'Uses Different Battery, With A Different Battery Design' 10/13/2016
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee 10/11/2016
Medtronic (MDT) Issues Urgent Safety Notices for Select ICDs, CRTds 9/30/2016
Medtronic (MDT) HeartWare (HTWR) Faces Two Class 1 FDA Recalls 9/30/2016
ResMed (RMD) Recalls Astral Ventillators Due to Internal Battery Issues 9/1/2016
19 Deaths Force Medtronic (MDT) to Warn Doctors on Heart Valve Delivery System 8/18/2016
FDA Hits 12 Medtech Firms With Warning Letters 8/18/2016
GlaxoSmithKline (GSK) Best-Selling Weight Loss Pill Cramped By Problematic Studies That Understated Its Harms 8/17/2016
Cook Medical Issues Global Recall of Roadrunner UniGlide Hydrophilic Wire Guides Due to Raw Materials Issue 8/12/2016
French Government Denies Cover-Up of Birth Defects Study Related to Sanofi (SNY) Epilepsy Drug 8/11/2016
10,000+ Women Took Sanofi (SNY)'s Anti-Epilepsy Drug Despite Risk to Fetuses 8/10/2016
Pharmascience Inc. Voluntarily Recalls One Lot Of Pms-Atenolol 100mg Due To A Labelling Error 8/8/2016
Draeger Medical Recalls Ventstar Oxylog 3000 Pediatric Breathing Circuits 8/8/2016
Deficiencies Force Pfizer (PFE) to Shut Down Indian Facility Temporarily 8/8/2016
Children Hospitalized Over Inno Pharma's Super Strong Vitamin D Supplement 8/5/2016
FDA Warns Chinese Drugmaker Xiamen Origin Biotech Over Making False Statements to Regulators 8/5/2016
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
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
AB Science (AB.PA) Release: Action Plan Following Warning Letter Has Been Validated By FDA 7/14/2016
Medtronic (MDT) Warns on Wire Fracture Risk with Activa DBS Devices 7/5/2016
FDA Hits Medtronic (MDT)'s TYRX with Warning Over Anti-Bacterial Envelopes 6/23/2016
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
Teva (TEVA) Suspends Marketing for ZECUITY in the U.S. 6/13/2016
Medtronic (MDT) Recalls Midas Rex Sagittal Saws on Leaky Seals Risk 6/3/2016
FDA Slaps Class 1 Tag on Medtronic (MDT)'s Capnostream Battery Pack Recall 5/31/2016
French Authorties Blame Both Biotrial and Bial Over Fatal Drug Trial 5/24/2016
Europe Lifts Warning on Pfizer (PFE)'s Smoking Cessation Drug Champix 5/23/2016
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
Sanofi (SNY) Recalls Some Batches of Combiflam in India 5/12/2016
Study Reveals More Than One-Third of Hip Implants Made by Johnson & Johnson (JNJ)'s DePuy Synthes Were the Wrong Size 4/29/2016
Good News for NeuroDerm (NDRM) as the FDA Removes Import Alert of Infusion Pumps Used in ND0612 Clinical Trials 4/22/2016
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
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
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
$90 Million China Vaccine Scandal Prompts Angry Backlash From Parents And Doctors 3/22/2016
FDA Warns India's Emcure Pharma for Repeatedly Fudging Data at Plant 3/17/2016
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
Maharashtra FDA to Test Johnson & Johnson (JNJ) Baby Powder for Cancer-Causing Substances After $75 Million U.S Verdict 3/10/2016
FDA Slaps ReWalk (RWLK) with Warning Letter for Failure to Submit Post-Market Surveillance Report for Exoskeleton 3/3/2016
UK Firm Bedfont Scientific Banned from Shipping Medical Devices to U.S. 2/24/2016
303 Fetal Deaths May be Linked to Bayer HealthCare (BAY)'s Essure; Congressman Raises New Concerns About Contraceptive Device 2/18/2016
Royal Philips Electronics N.V. (PHG) Issues a Set of Urgent Safety Notice for Allura Systems 2/2/2016
FDA Discovers Wockhardt (WOCKHARDT.BO) Hid Failed Tests and Deleted Data at Indian Plant 2/1/2016
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
Ex-GlaxoSmithKline (GSK) Biostatistician Sues, Claims He was Let Go Over Nicoderm Studies 1/13/2016
Cadila Healthcare Shares Plunge After FDA Warning 12/31/2015
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
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
About One in Five Patients Taking AstraZeneca PLC (AZN)'s Brilinta Stopped Due to Side Effects 11/13/2015
Novartis AG (NVS)'s Japanese Unit in Trouble Again for Failing to Report Drug Side Effects on Time 11/12/2015
Dr. Reddy's Laboratories Ltd. (RDY) Drops the Most in 11 Years on FDA Warning 11/9/2015
European Medicines Agency Recommends Suspension Of Medtronic (MDT)'s Implant Inductos 10/23/2015
Sientra (SIEN) Temporarily Halts U.S. Sale of Devices Manufactured by Silimed 10/12/2015
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
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
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
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
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
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
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
New Book Claims Grunenthal GmbH Knew About Thalidomide Risk Six Months Before Drug Was Pulled 5/26/2015
GlaxoSmithKline (GSK) Recalls Flu Vaccine Over Potency Issues 4/21/2015
FDA Panel Wants Heart Risk Warnings for AstraZeneca PLC (AZN), Takeda (TKPYY) Diabetes Drugs 4/16/2015
Hospira Slapped Again By the FDA for Plant Problems 4/16/2015
Advisory - Jamp Pharma Corp Recalls Jamp-Methotrexate (USP 50mg/2mL) Due To Particulate Matter 3/16/2015
Novartis AG (NVS)'s Much-Anticipated New Heart Drug May Be Linked to Alzheimer's Disease 2/13/2015
Growth Concerns Loom for Daiichi Sankyo (4568.t) on Drug Warning 2/9/2015
Eli Lilly (LLY) Claims Innocence as FDA Bans Mystery Cialis-Viagra Concoction Discovered at Plant 1/14/2015
Information Update - Health Products From Sri Krishna Pharmaceuticals Quarantined Due to Data Integrity Concerns 1/7/2015
Health Canada Release: "Hydro-Lean" Weight Loss Product Seized From Two Calgary Stores Due To Serious Safety Risks 12/24/2014
Germany Bans 80 Drugs For Insufficient Trials By gvk bioSciences Private Limited 12/11/2014
gvk bioSciences Private Limited Manipulated Data, Will Re-Do All Clinical Studies For Drugmakers 12/9/2014
Novartis AG (NVS) Flu Vaccine FLUAD Suspended Following 13 Reported Deaths 12/3/2014
Sun Pharmaceutical Industries Ltd (SUNPHARMA.NS) Recalls 68,194 Bottles Of Anti-Depression Drug In U.S. 11/17/2014
Novo Nordisk A/S (NVO) Receives U.S. Subpoena Related To Danish Factory 10/27/2014
Hikma Pharmaceuticals (HIK.L) Falls On FDA Warning For Portugal Plant 10/24/2014
Mylan Inc. (MYL) Recalls Certain Lots Of Mylan-Nitro Sublingual Spray 10/15/2014
Biomedic Acetaminophen With Codeine: Recall Due To Missing Child-Resistant Packaging 9/29/2014
FDA Says Novartis AG (NVS), Roche (RHHBY)'s Asthma Drug Xolair Raises Risk Of Heart, Brain Problems 9/29/2014
GlaxoSmithKline (GSK) Deals With Fallout From Polio Virus Spill 9/23/2014
Hundreds Of Girls Struck With Mystery Illness; Possibly Linked To Merck & Co. (MRK)'s Gardasil 8/29/2014
Teva Pharmaceutical Industries Limited (TEVA) Recalls Parkinson's Disease Medication As It May Be "Super Potent" 8/28/2014
Dr. Reddy's Laboratories, Inc. (RDY)'s Breached Packaging Rules: U.S. Regulator 8/21/2014
FDA Finds Falsified Data, Serious Mold, And Decaying Frogs At Amanta (Formerly Known As Marck Biosciences) 8/21/2014
Sun Pharmaceutical Industries Ltd (SUNPHARMA.NS) Unit Recalls Mutiple Lots Of Capsules From U.S. 8/15/2014
Novartis AG (NVS) Apologizes For Not Disclosing Side-Effects Of Leukemia Drugs Sooner 8/1/2014
Boehringer Ingelheim GmbH Withheld Evidence On Blockbuster Blood Thinner 7/24/2014
GlaxoSmithKline (GSK) Recalls Painkiller In Puerto Rico 7/16/2014
Sun Pharmaceutical Industries Ltd (SUNPHARMA.NS) Recalls Over 40,000 Bottles Of Antidepressant 7/11/2014
Sun Pharmaceutical Industries Ltd (SUNPHARMA.NS) Recalls 200 Vials Of Cancer Drug Gemcitabine: FDA 7/3/2014
FDA Slaps GlaxoSmithKline (GSK) With Warning For Plant Quality Violations, Orders Company To Review Manufacturing Worldwide 6/26/2014
Dr. Reddy's Laboratories Ltd. (RDY) Recalls Over 13,000 Bottles Of Hypertension Drug 6/20/2014
Novartis Pharma K.K. (NVS) Says 10,000 Side Effect Cases Were Never Filed 6/17/2014
FDA Cites Manufacturing Concerns At Wockhardt (WOCKHARDT.BO)'s U.S. Unit 5/28/2014
Ranbaxy Laboratories (RANBAXY.BO) Recalls Nearly 30,000 Packs Of Allergy-Relief Drug In U.S. 5/6/2014
Glenmark Pharmaceuticals Pulls 2,900 Bottles Of Ulcer Drug In U.S. 4/21/2014
FDA Finds Contaminated Drug Ingredient At GlaxoSmithKline (GSK) Ireland Plant 4/2/2014
Hikma Pharmaceuticals Says FDA Lifts Warning On Eatontown Facility 4/2/2014
GlaxoSmithKline (GSK) Recalls Weight-Loss Drug Alli In U.S. After Tampering 3/27/2014
Dr. Reddy's Laboratories Ltd. (RDY) Recalls Heartburn Drug In U.S. 3/13/2014
More Trouble As Ranbaxy Laboratories (RANBAXY.BO) Recalls More Than 60,000 Bottles Of Generic Lipitor In U.S. 3/11/2014
Ranbaxy Pharmaceuticals Inc. Suspends Shipments From Two Plants 2/25/2014
FDA To Review Possible Heart Risks With AstraZeneca PLC (AZN)'s Diabetes Drug 2/12/2014
Risk Seen With Merck & Co., Inc. (MRK)-GlaxoSmithKline (GSK) Rotavirus Vaccines 1/14/2014
Shenzhen Kangtai's Hepatitis B Vaccine Implicated In Six Deaths 12/27/2013
Novartis AG (NVS) Recalls Some Cough And Cold Syrup In UK Due To Defect 12/13/2013
EU Clears Roche (RHHBY) For Failing To Report Side Effects 11/19/2013
Study Supporting Daiichi Sankyo, Inc. (4568.t) Promotional Materials Pummeled By FDA In New Untitled Letter 11/13/2013
Sanofi (France) (SAN.PA)'s Lemtrada Drug May be Too Risky, FDA Staff Says 11/8/2013
FDA Updates Warning on Sanofi (France) (SAN.PA)'s Blood Thinner Lovenox 11/7/2013
Novo Nordisk A/S (NVO) Recalls Batches of FelxPen, Penfill Insulin in Europe 10/25/2013
Boehringer Ingelheim Corporation's Pradaxa Topped FDA Side Effect Reports 10/18/2013
British Drug Regulator Recalls Five Wockhardt (WPL) Drugs 10/17/2013
Celgene Corporation (CELG) Warns UK Docs of Imnovid Birth Defects Risk 10/14/2013
Trouble for Bliss GVS Pharma Drug in Ghana 10/8/2013
What Did Mylan Inc. (MYL) Get for $1.6 Billion? A Vaccine Maker With a Troubled Factory 9/25/2013
AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY) Recall Bydureon Diabetes Drug for Under-Filled Vials 9/20/2013
Tobinco to Compensate Customers on the Recall of Gsunate Plus Suppository by FDA 9/17/2013
Ranbaxy Laboratories (RANBAXY.BO) Crashes on FDA Import Alert for Mohali Unit; Stock Falls -30.27% at Market Close (September 16, 2013) 9/16/2013
Novartis AG (NVS)'s OTC Unit Messes Up Again, Recalls 4 Million Bottles of Maalox 8/30/2013
Dr. Reddy's Laboratories Ltd. (RDY) Recalls Anti-Gas Tablets in the U.S. 8/22/2013
Fabupharm Accused of Selling Outdated Medicine 8/19/2013
Patient Taking Novartis AG (NVS) MS Pill Developed Rare Disease 8/1/2013
BTG plc (BTG.L) Halts Production at Facility Hit With Warning Letter 7/18/2013
UK Yanks 16 of Wockhardt's Drugs for Production Failures 7/12/2013
Teva Pharmaceutical Industries Limited (TEVA) Victim of Product Tampering - Report 6/13/2013
"Suspicious" Death in France After Teva Pharmaceutical Industries Limited (TEVA) Medicine Alert 6/11/2013
GlaxoSmithKline (GSK) Probes Allegedly Fraudulent Data in Study Written by Employees 6/11/2013
GlaxoSmithKline (GSK)'s Avandia Vote Ends an Era of Drug Safety Scandals 6/10/2013
Apollo Pharmacy Halts Sale of Ranbaxy Laboratories (RANBAXY.BO) Drugs 6/10/2013
Another Novartis AG (NVS) Manufacturing Facility Gets an FDA Lashing 6/6/2013
Johnson & Johnson (JNJ) Recalls 32 Million Boxes of Contraceptives From 43 Countries 6/5/2013
FDA Raises Safety Concerns at Hospira, Inc. (HSP) Plant in India 5/30/2013
Fresenius Kabi AG Voluntarily Recalls One Lot of Magnesium Sulfate Injection 5/28/2013
Those Johnson & Johnson (JNJ) Recalls Keep on Coming: Tylenol Bottles Yanked From Brazil 5/23/2013



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