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FDA MedWatch Safety Alerts



Last Build Date: Thu, 14 Dec 2017 08:00:00 -0500

 



Blue Pearl All Natural Male Enhancement Supplement: Recall - Undeclared Drug Ingredient

Thu, 14 Dec 2017 08:00:00 -0500

Undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.



Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues

Tue, 05 Dec 2017 10:00:00 -0500

The use of impacted alcohol prep pads could result in adverse events such as infections.



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

Tue, 05 Dec 2017 07:30:00 -0500

UPDATED 12/05/2017. Anyone currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis.



Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory - Fading Print On Label

Fri, 01 Dec 2017 08:30:00 -0500

Potential for fading print, with more effect on the expiration dating on the patient tear off portion of the vial label.



Bull Capsules, Chao Jimengnan Tablets by Nutra Labs: Recall - Undeclared Drug Ingredients

Fri, 01 Dec 2017 08:10:00 -0500

Undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening.



Biotin (Vitamin B7): Safety Communication - May Interfere with Lab Tests

Tue, 28 Nov 2017 09:00:00 -0500

Biotin in patient samples can cause falsely high or falsely low results, depending on the test. Incorrect test results may lead to inappropriate patient management or misdiagnosis.



Riomet (Metformin Hydrochloride Oral Solution): Recall - Microbial Contamination

Mon, 27 Nov 2017 10:10:00 -0500

Use of the affected product potentially could result in a risk of infection, especially in an immunocompromised patient.



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

Fri, 17 Nov 2017 00:00:00 -0500

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



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

Wed, 15 Nov 2017 13:20:00 -0500

Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences.



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

Wed, 15 Nov 2017 11:00:00 -0500

Preliminary safety trial results in over 6,000 patients with gout being evaluated.



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

Tue, 14 Nov 2017 10:00:00 -0500

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.



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

Wed, 08 Nov 2017 15:00:00 -0500

Parenteral drugs, including compounded injectable drugs, with a high pH may lead to skin damage or other unintended health consequences.



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

Mon, 06 Nov 2017 08:30:00 -0500

If the user incorrectly places the defibrillation electrodes, it may result in ineffective energy delivery to the patient and serious injury or death.



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

Mon, 06 Nov 2017 08:00:00 -0500

Risk of decreased quality and consistency (i.e., the safety, identity, strength, quality and purity)



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

Mon, 23 Oct 2017 08:00:00 -0400

Suspend further administration of octagam 10% from production lots K724B8541 and K725A8541.



Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination

Sat, 21 Oct 2017 00:00:00 -0400

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



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

Thu, 19 Oct 2017 15:30:00 -0400

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.



A1 Slim by Kiriko: Recall - Undeclared Drug Ingredients

Sat, 07 Oct 2017 00:00:00 -0400

Product tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.



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

Fri, 06 Oct 2017 11:00:00 -0400

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.



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

Tue, 03 Oct 2017 15:00:00 -0400

Prophylactic use of intraocular vancomycin, alone or in a compounded drug, during cataract surgery is generally not recommended because of the risk of HORV.