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  • Feb 2, 2016 - MedWatch Drug Updates

FDA recommends not to purchase "Bentonite Me Baby" by Alikay Naturals

FDA issued warning against use of “Bentonite Me Baby- Bentonite clay” by Alikay Naturals due to potentail risk of lead poisoning

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  • Feb 2, 2016 - MedWatch Drug Updates

FDA urges consumers to discontinue use of Crema Piel De Seda (Silky Skin Cream) by Viansilk

FDA has warned not to purchase or use a skin whitening cream called “Crema Piel De Seda,” due to the risk of mercury poisoning

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  • Feb 2, 2016 - MedWatch Drug Updates

Class I Recall of SPOTCHEM II Test Strips by Arkray due to inaccurate blood sugar reading

Arkray has recalled SPOTCHEM II Basic PANEL-1 Reagent and SPOTCHEM II Glucose Reagent Test Strip due to inaccurate blood sugar readings

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  • Feb 2, 2016 - MedWatch Drug Updates

Recall of Pink Bikini and Shorts on the Beach Dietary Supplements by Lucy's Weight Loss System - Contains undeclared drug ingredient

Recall of all lots of Pink Bikini and Shorts on the Beach dietary supplement by Lucy's Weight Loss System due to presence of undeclared drug ingredients, sibutramine, phenolphthalein, and/or diclofenac.

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  • Jan 28, 2016 - MedWatch Drug Updates

Class I Recall of Optisure Dual Coil Defibrillation Leads by St. Jude Medical due to a manufacturing error

St. Jude has recalled the Optisure dual Coil Defibrillation Leads due to a manufacturing error that may have caused damage to the coils which may prevent patient therapy

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  • Jan 28, 2016 - MedWatch Drug Updates

Recall of IV solutions by Baxter due to potential for leaking containers and particulate matter

Recall of four lots of Baxter intravenous (IV) solutions due to the potential for leaking containers and particulate matter, resulting in contamination of the solution

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  • Jan 19, 2016 - MedWatch Drug Updates

Recall of unexpired sterile human and animal compounded products by Abbott's compounding pharmacy

Recall of all lots of unexpired sterile human and animal compounded products by Abbott's Compounding Pharmacy due to concerns of lack of sterility assurance

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  • Jan 19, 2016 - MedWatch Drug Updates

Safety alert against use of Licorice OTC Cough Syrup by Ma Ying Long Pharmaceutical Group

FDA issued warning against Licorice OTC Cough Syrup by Ma Ying Long Pharmaceutical Group due to presence of unidentified morphine

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  • Jan 14, 2016 - MedWatch Drug Updates

Recall of children's guaifenesin grape liquid and guaifenesin DM cherry liquid by Perrigo Company

Recall of children's guaifenesin grape liquid and guaifenesin DM cherry liquid by Perrigo Company, as some packages contain an oral dosing cup with incorrect dose markings

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  • Jan 12, 2016 - MedWatch Drug Updates

Class 1 Recall of Pleural and Pneumopericardial Drainage Sets by Stryker Fuhrman as catheter may break during insertion

Stryker Fuhrman recalled Pleural and Pneumopericardial Drainage sets as they received reports that the catheter in the Drainage Set broke off in the pleural cavity during Insertion

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  • Jan 11, 2016 - MedWatch Drug Updates

Recall of Multiple Products by R Thomas Marketing due to presence of undeclared drug ingredient

Recall of multiple products marketed as dietary supplements for male sexual enhancement by R Thomas Marketing as they found to contain undeclared drug ingredient sildenafil

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  • Jan 6, 2016 - MedWatch Drug Updates

Recall of IV solutions by Baxter due to potential presence of particulate matter

Recall of two lots of Baxter intravenous (IV) solutions due to the potential presence of particulate matter identified as insect

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  • Jan 5, 2016 - MedWatch Drug Updates

Noxafil (posaconazole) – Dosing errors when switching between different oral formulations

Differences in dosing regimens between the two oral formulations of antifungal Noxafil (posaconazole) have resulted in dosing errors; to prevent this drug label were revised

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  • Jan 4, 2016 - MedWatch Drug Updates

Recall of 4mg (16mcg/mL) and 8mg (32mcg/mL) Norepinephrine Bitartrate added to 0.9% NaCl in a 250mL Viaflex Bag by Pharmedium

Recall of 29 lots of 4mg (16mcg/mL) and 3 lots of 8mg (32mcg/mL) Norepinephrine Bitartrate added to 0.9% NaCl in a 250mL Viaflex Bag by Pharmedium due to slight discoloration in the admixture

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  • Dec 28, 2015 - MedWatch Drug Updates

Safety alert against use of ED-530XT duodenoscopes by FUJIFILM Medical Systems

Revised, validated manual reprocessing instructions for the ED-530XT duodenoscope by FUJIFILM Medical Systems to replace those provided in the original device labeling

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  • Dec 28, 2015 - MedWatch Drug Updates

Recall of various products distributed for weight loss by Bee Extremely Amazed

Bee Extremely Amazed LLC voluntarily recalled various products distributed for weight loss due to presence of undeclared drug sibutramine and/or phenolphthalein

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  • Dec 24, 2015 - MedWatch Drug Updates

Recall of Apexxx by Nuway Distributors due to presence of undeclared drug ingredients

Nuway Distributors has recalled all lots of Apexxx, a dietary supplement for male sexual enhancement, as it was found to contain undeclared PDE-5 Inhibitor, sildenafil

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  • Dec 24, 2015 - MedWatch Drug Updates

Class I Recall of Perseus A500 anesthesia workstation by Draeger due to faulty power switch

Draeger has recalled Perseus A500 anesthesia workstation due to faulty power switch which may fail causing the workstation to alarm and shut down unexpectedly

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  • Dec 23, 2015 - FDA Drug Updates

FDA approved Uptravi (selexipag) for Pulmonary Arterial Hypertension

FDA approved Uptravi (selexipag) an oral IP prostacyclin receptor agonists for adults with Pulmonary Arterial Hypertension

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  • Dec 23, 2015 - FDA Drug Updates

FDA approved Zurampic (lesinurad) for Gout

FDA approved Zurampic (lesinurad) for hyperuricemia associated with gout

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  • Dec 16, 2015 - FDA Drug Updates

FDA approved Bridion (sugammadex) to reverse effects of neuromuscular blocking drugs

FDA approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium and vecuronium used during surgery

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  • Dec 14, 2015 - FDA Drug Updates

FDA approved Alecensa (alectinib) to treat ALK-positive lung cancer

FDA approved Alecensa (alectinib) to treat advanced (metastatic) ALK-positive non-small cell lung cancer, worsened after or intolerant to crizotinib therapy

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  • Dec 14, 2015 - MedWatch Drug Updates

Recall of Chariot Guiding Sheath by Boston Scientific due to risk of shaft separation

Recall of Chariot Guiding Sheath by Boston Scientific due to the risk of shaft separation during device preparation or use, causing severe adverse health events

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  • Dec 10, 2015 - MedWatch Drug Updates

Baclofen active pharmaceutical ingredient from Taizhou Xinyou Pharmaceutical and Chemical may contain contamination

FDA warns that certain lots of baclofen active pharmaceutical ingredient (API) from Taizhou Xinyou Pharmaceutical & Chemical may contain particulates contamination

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  • Dec 10, 2015 - MedWatch Drug Updates

Recall of Pink Bikini Dietary Supplement by Lucy's Weight Loss System as it was found to contain diclofenac

All lots of Pink Bikini White powder Capsules were voluntarily recalled by Lucy's Weight Loss System, as it was found to contain undeclared drug ingredient, diclofenac

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  • Dec 9, 2015 - FDA Drug Updates

FDA approved Kanuma (sebelipase alfa) to treat a rare enzyme disorder, lysosomal acid lipase deficiency

FDA approved Kanuma (sebelipase alfa) to treat rare enzyme disorder, lysosomal acid lipase deficiency (known as Wolman disease and cholesteryl ester storage disease)

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  • Dec 9, 2015 - FDA Drug Updates

FDA approved Vonvendi [von Willebrand factor (Recombinant)] for von Willebrand disease

FDA approved Vonvendi [von Willebrand factor (Recombinant)] for adults >=18 years with von Willebrand disease

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  • Dec 8, 2015 - MedWatch Drug Updates

Class I Recall of Inspiration LS, 5i and 7i ventilator systems by eVent Medical - May shut down without sounding an alarm

Urgent recall of LS, 5i, or 7i Inspiration ventilators by eVent Medical as it may shut down without sounding an alarm causing serious health injury or death

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  • Dec 7, 2015 - MedWatch Drug Updates

SGLT2 inhibitors: FDA added new warnings about too much acid in the blood and serious urinary tract infections

FDA added warnings to the labels of SGLT2 inhibitors, a type II diabetes medicines, about risks of too much acid in the blood and of serious urinary tract infections

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  • Dec 7, 2015 - MedWatch Drug Updates

Recall of Lipo Escultura as it was found to contain sibutramine and diclofenac

Lipo Escultura Corp. of Brooklyn, NY are voluntarily recalling all Lipo Escultura capsules as they have been found to contain sibutramine and diclofenac

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  • Dec 3, 2015 - MedWatch Drug Updates

OmniPod Insulin Management System by Insulet - Cases of needle mechanism deployment failure or delay

A safety alert has been issued against use of OmniPod Insulin Management System by Insulet due to needle mechanism deployment failure or delay

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  • Dec 2, 2015 - MedWatch Drug Updates

Recall of Digital Temple Thermometer (DTT) by K-Jump Health

FDA has issued a recall of Digital Temple Thermometer (DTT) manufactured by K-Jump Health due to an inaccurate temperature display by the device

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  • Dec 1, 2015 - FDA Drug Updates

FDA approved Empliciti (elotuzumab) for multiple myeloma

FDA approved Empliciti (elotuzumab) in combination with two other therapies for patients with multiple myeloma

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  • Nov 30, 2015 - MedWatch Drug Updates

Recall of RotaWire Elite Guidewire and wireClip Torquer Guidewire by Boston Scientific

Recall of RotaWire Elite Guidewire and wireClip Torquer Guidewire by Boston Scientific as they may break and separate from the Rotablator System

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  • Nov 26, 2015 - MedWatch Drug Updates

Recall of compounded multivitamin capsules by Glades Drugs

Recall of compounded multivitamin capsules by Glades Drugs due to presence of high amounts of vitamin D3 (Cholecalciferol)

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  • Nov 25, 2015 - FDA Drug Updates

FDA approved Portrazza (necitumumab) for Non-Small Cell Lung Cancer

FDA approved Portrazza (necitumumab) for Advanced Squamous Non-Small Cell Lung Cancer

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  • Nov 25, 2015 - FDA Drug Updates

FDA approved Fluad, the first seasonal influenza vaccine containing an adjuvant

FDA approved Fluad, a new trivalent influenza vaccine containing an adjuvant for prevention of seasonal influenza in people >= 65 years

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  • Nov 24, 2015 - MedWatch Drug Updates

Safety alert against the use of intravascular medical devices due to possibility of lubricious coating separation

FDA warn against the possibility of hydrophilic and/or hydrophobic coatings separation from intravascular medical devices

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  • Nov 23, 2015 - FDA Drug Updates

FDA approved Ninlaro (ixazomib) for multiple myeloma

FDA approved Ninlaro (ixazomib) for patients with relapsed or refractory multiple myeloma

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  • Nov 19, 2015 - FDA Drug Updates

FDA approved Narcan, easy-to-use nasal spray to treat opioid overdose

FDA approved Narcan nasal spray, the first approved nasal spray version of naloxone, to stop or reverse the effects of an opioid overdose

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  • Nov 18, 2015 - MedWatch Drug Updates

Drug safety alert: Iodine-containing contrast agents may cause underactive thyroid in infants

Iodine-containing Contrast Agents- Rare cases of underactive thyroid have been reported in infants

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  • Nov 18, 2015 - MedWatch Drug Updates

Class I Recall of G5 Ventilator by Hamilton due to ventilation and alarm failure

Class I Recall of G5 Ventilator by Hamilton – Ventilator may stop working without sounding an alarm

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  • Nov 17, 2015 - FDA Drug Updates

Device Safety Alert: Endoscope washer/disinfectors by Custom Ultrasonics - Firm’s continued violations of federal law

FDA recommends Health Care Facilities using Custom Ultrasonics Automated Endoscope Reprocessors to use alternate reprocessing methods

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  • Nov 17, 2015 - FDA Drug Updates

FDA approved Darzalex (daratumumab) for multiple myeloma

FDA approved Darzalex (daratumumab), a monoclonal antibody for patients with previously treated multiple myeloma

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  • Nov 17, 2015 - FDA Drug Updates

FDA approved Tagrisso (osimertinib) for Non-Small Cell Lung Cancer

FDA approved Tagrisso (osimertinib), a kinase inhibitor for EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer

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  • Nov 16, 2015 - FDA Drug Updates

FDA approved Cotellic (cobimetinib) as part of combination treatment for advanced melanoma

FDA approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma with abnormal gene (BRAF V600E or V600K mutation).

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  • Nov 16, 2015 - FDA Drug Updates

FDA approved antihemophilic factor (Recombinant), PEGylated for hemophilia A

FDA approved Adynovate, Antihemophilic Factor (Recombinant), PEGylated, a modified antihemophilic factor for prevention and control of bleeding in Hemophilia A patients

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  • Nov 10, 2015 - FDA Drug Updates

FDA approved first oncolytic virus therapy, for the treatment of melanoma

FDA approved Imlygic (talimogene laherparepvec), the first oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes

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  • Nov 9, 2015 - MedWatch Drug Updates

FDA: Drug safety alert- Plavix (clopidogrel) - Long-term treatment does not change risk of death

FDA review determined that long-term treatment of Plavix (clopidogrel) does not increase or decrease risk of death

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  • Nov 6, 2015 - FDA Drug Updates

FDA approved new combination treatment for HIV

FDA approved Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) combination of an antiretroviral drugs for the treatment of HIV-1 infection

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