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FDA MedWatch Safety Alerts
Updated: 1 hour 5 min ago

Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems

Tue, 11/21/2017 - 10:30
Anyone who is currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis. Posted 11/21/2017
Categories: Health News - Safety

Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone: Recall - Possible Sub Potent and Super Potent Tablets

Fri, 11/17/2017 - 10:30
The use of this product in patients with uncontrolled diarrhea due to chronic medical conditions may predispose the patient to toxicity from either the diphenoxylate or atropine components. Posted 11/17/2017
Categories: Health News - Safety

Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection: Recall - Presence Of Particulate Matter

Wed, 11/15/2017 - 23:50
Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences.
Categories: Health News - Safety

Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death

Wed, 11/15/2017 - 21:30
Preliminary safety trial results in over 6,000 patients with gout being evaluated.
Categories: Health News - Safety

Injectable Silicone for Body Contouring and Enhancement: FDA Safety Communication - FDA Warns Against Use

Tue, 11/14/2017 - 20:30
Silicone, when injected into areas with many blood vessels, can travel to other parts of the body and block blood vessels in the lungs, heart, or brain. This can result in permanent damage to those tissues and lead to stroke or death.
Categories: Health News - Safety

Compounded Glutamine, Arginine, and Carnitine Product for Injection by United Pharmacy: Compounding Risk Alert - FDA Investigates Two Adverse Events

Thu, 11/09/2017 - 01:30
Parenteral drugs, including compounded injectable drugs, with a high pH may lead to skin damage or other unintended health consequences.
Categories: Health News - Safety

Infant/Child Reduced Energy Defibrillation Electrodes by Cardinal Health: Voluntary Field Action - Incorrect Artwork on Packaging

Mon, 11/06/2017 - 19:00
If the user incorrectly places the defibrillation electrodes, it may result in ineffective energy delivery to the patient and serious injury or death.
Categories: Health News - Safety

Ridge Properties DBA Pain Relief Naturally Products: Recall - Manufacturing Concerns at the Facility

Mon, 11/06/2017 - 18:30
Risk of decreased quality and consistency (i.e., the safety, identity, strength, quality and purity)
Categories: Health News - Safety

Octagam [Immune Globulin Intravenous (human)] 10 Percent Liquid Preparation]: Voluntary Market Withdrawal

Mon, 10/23/2017 - 17:30
Suspend further administration of octagam 10% from production lots K724B8541 and K725A8541.
Categories: Health News - Safety

Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination

Sat, 10/21/2017 - 09:30
Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. Posted 10/21/2017
Categories: Health News - Safety

Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication - Batteries May Fail Earlier Than Expected

Fri, 10/20/2017 - 01:00
UPDATED 10/19/2017. St. Jude Medical notified physicians of the Battery Performance Alert (BPA), a new tool that detects and notifies physicians of abnormal battery performance that may lead to premature battery depletion.
Categories: Health News - Safety

A1 Slim by Kiriko : Recall - Undeclared Drug Ingredients

Sat, 10/07/2017 - 09:30
Product tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.
Categories: Health News - Safety

Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall - One Shipment of Product Exposed to Subfreezing Temperatures

Fri, 10/06/2017 - 20:30
When subjected to freezing, emulsion droplets will increase in size, forming aggregates that can block pulmonary circulation/lead to serious adverse health consequences that can be life-threatening.
Categories: Health News - Safety

Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation: FDA Statement - Case of Hemorrhagic Occlusive Retinal Vasculitis

Wed, 10/04/2017 - 00:30
Prophylactic use of intraocular vancomycin, alone or in a compounded drug, during cataract surgery is generally not recommended because of the risk of HORV.
Categories: Health News - Safety

Infant Sleep Positioners: FDA Warning - Risk of Suffocation

Tue, 10/03/2017 - 19:30
FDA reminding parents and caregivers not to put babies in sleep positioners. These products, sometimes also called “nests” or “anti-roll” products, can cause suffocation that can lead to death.
Categories: Health News - Safety

Endovascular Graft Systems: Letter to Health Care Providers - Type III Endoleaks Associated with Use

Thu, 09/28/2017 - 20:30
Type III endoleak may require treatment with additional interventions such as re-lining, insertion of additional endograft components, or open surgical repair. Interventions to address endoleaks carry added risks for impacted patients.
Categories: Health News - Safety

Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Class I Recall - Clinical Issue

Tue, 09/26/2017 - 04:00
If device with blocked guidewire lumen were used, device would not be positioned correctly and hemorrhage would not be controlled, delaying life-saving treatment, which may result in serious adverse health consequences, including death.
Categories: Health News - Safety

TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortality and Neurological Adverse Event Results

Mon, 09/25/2017 - 23:00
UPDATED 09/25/2017. Most recent interim results from the ongoing SynCardia TAH-t post-approval study looking at mortality and neurological adverse events.
Categories: Health News - Safety

Vegetable Vigra by Natures Supplement: Recall - Undeclared Drug Ingredient

Thu, 09/21/2017 - 22:30
Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that, taken with this product, could lower blood pressure to dangerous levels that could be life-threatening.
Categories: Health News - Safety

Ocaliva (obeticholic acid): Drug Safety Communication - Increased Risk of Serious Liver Injury

Thu, 09/21/2017 - 19:30
Reports of Ocaliva being incorrectly dosed in some patients with moderate to severe decreases in liver function. Some patients received a higher frequency of dosing than is recommended in the drug label.
Categories: Health News - Safety

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