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Warfarin 2 mg Tablets Zydus Pharmaceuticals Recall
Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall – Due to Oversized Tablet 06/12/2013 AUDIENCE: Pharmacy, Patient, Health Professional ISSUE: Zydus Pharmaceuticals USA Inc. is...
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MedWatch May 2013 Safety Labeling Change
The MedWatch May 2013 Safety Labeling Changes posting includes 40 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE...
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Cybersecurity for Medical Devices and Hospital Networks
Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication AUDIENCE: Biomedical Engineering, Health Professional, Risk Manager ISSUE: FDA is recommending that medical device...
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Endologix Inc AFX Introducer System Class 1 Recall
Endologix, Inc. AFX Introducer System: Class 1 Recall – Reports Of Dilator Breaking During Procedures AUDIENCE: Risk Manager, Health Professional ISSUE: On May 13, 2013, Endologix, Inc. initiated a...
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Zyprexa Relprevv Olanzapine Pamoate Drug Safety Communication
Zyprexa Relprevv (Olanzapine Pamoate): Drug Safety Communication – FDA Investigating Two Deaths Following Injection AUDIENCE: Health Professional, Pharmacy, Patient ISSUE: FDA is investigating two...
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Enteric Coated Aspirin 81 mg Tablets Advance Pharmaceutical Recall
Enteric Coated Aspirin 81 mg Tablets by Advance Pharmaceutical Inc.: Recall of One Lot – May Contain Acetaminophen 500 mg Tablets 06/19/2013 AUDIENCE: Consumer, Pharmacy, Health Professional ISSUE:...
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Estarylla norgestimate and ethinyl estradiol Recall
Estarylla (norgestimate and ethinyl estradiol): Recall – Report of Placebo Tablet Present in Row of Active Tablets AUDIENCE: Pharmacy, Patient ISSUE: Sandoz notified the public it is conducting a...
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Verathon, Inc GlideScope Video Laryngoscope 3, 4, 5 and GlideScope 2, 3, 4...
Verathon, Inc., GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 Reusable Blades: Class I Recall – Risk of Blade Tip Breakage and Premature Failure AUDIENCE: Risk Manager...
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MedWatch June 2013 Safety Labeling Changes
The MedWatch June 2013 Safety Labeling Changes posting includes over 44 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS,...
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Medtronic MiniMed Paradigm Insulin Infusion Sets Class 1 Recall
Medtronic MiniMed Paradigm Insulin Infusion Sets: Class 1 Recall – Potential for Over or Under Delivery of Insulin AUDIENCE: Consumer, Patient, Health Professional ISSUE: On June 7, 2013, Medtronic...
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Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube Class 1 Recall
Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: Class 1 Recall – Mislabeled Packaging AUDIENCE: Anesthesiology, Emergency Medicine, Nursing, Pediatrics, Risk Manager ISSUE: The outside of the device...
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MedStream Programmable Infusion Pump Class 1 Recall
MedStream Programmable Infusion Pump: Class 1 Recall – Malfunction In The Fill Level Sensor AUDIENCE: Health Professional, Risk Manager ISSUE: The Fill Level Sensor (FLS), a component of the Medstream...
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Diabetes Treatments FDA Alerts of Illegal Sales Undeclared Ingredients
Diabetes Treatments: FDA Alerts of Illegal Sales – Undeclared Ingredients AUDIENCE: Consumer, Health Professional ISSUE: FDA is taking action to remove from the market illegal products, including some...
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LeMaitre Vascular Inc Albograft Vascular Graft Class I Recall
LeMaitre Vascular, Inc., Albograft Vascular Graft: Class I Recall – Blood Leak Models: AMC1408, AMC1506, AMC1608, AMC1809, AMC1810, AMC2010, AMC4007, AMC4008, AMC6006, AMC6007, AMC6008, ATC1526,...
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Nizoral ketoconazole Drug Safety Communication
Nizoral (ketoconazole): Drug Safety Communication – Potentially Fatal Liver Injury, Risk of Drug Interactions and Adrenal Gland Problems AUDIENCE: Internal Medicine, Infectious Disease ISSUE: FDA is...
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Healthy Life Chemistry By Purity First B50
Healthy Life Chemistry By Purity First B-50: FDA Health Risk Warning – Undeclared Ingredients AUDIENCE: Consumer, Health Professional ISSUE: FDA is warning consumers that they should not use or...
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Mefloquine Hydrochloride Drug Safety Communication
Mefloquine Hydrochloride: Drug Safety Communication – Label Changes Due To Risk of Serious Psychiatric and Nerve Side Effects AUDIENCE: Infectious Disease, Emergency Medicine, Psychiatry, Pharmacy,...
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Nova Max Glucose Test Strips Recall
Nova Max Glucose Test Strips: Recall – May Report False, Abnormally High Blood Glucose Result AUDIENCE: Consumer, Family Physician, Pharmacy ISSUE: Nova Diabetes Care initiated a voluntary recall of 21...
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GE Healthcare Nuclear Medicine Systems Class I Recall
GE Healthcare Nuclear Medicine Systems: Class I Recall – Serious Injuries or Deaths Could Occur [Posted 07/29/2013] AUDIENCE: Nuclear Medicine, Radiology, Risk Manager, Biomedical Engineering ISSUE: GE...
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Beacon Hill Medical Pharmacy Rxtra Solutions Recall
Beacon Hill Medical Pharmacy/Rxtra Solutions: Recall – Lack of Sterility Assurance AUDIENCE: Consumers, Pharmacy ISSUE: Beacon Hill Medical Pharmacy and FDA is notifying health professionals and...
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