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FDA MedWatch Safety Alerts



Last Build Date: Fri, 18 Aug 2017 15:30:00 -0400

 



Sterile Drug Products by Bella Pharmaceuticals: Recall - Lack of Sterility Assurance

Fri, 18 Aug 2017 15:30:00 -0400

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.



Sterile Drug Products from Vital Rx, dba Atlantic Pharmacy and Compounding: FDA Alert - Lack of Sterility Assurance

Fri, 18 Aug 2017 11:00:00 -0400

UPDATED 08/18/2017. Recall issued for all lots of all compounded injectable prescription medications. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.



Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Class I Recall - Potential Formation of Thrombus Inside Device

Wed, 16 Aug 2017 12:00:00 -0400

Thrombus may form inside the device after implantation. Thrombosis or occlusion may lead to serious adverse health consequences, including death.



Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals: Recall - Misprinted Dosing Droppers

Wed, 16 Aug 2017 07:00:00 -0400

Significant probability of serious health consequences if more than the prescribed dose is dispensed, including: drowsiness causing trauma; increased anxiety; and risk of accidental injury to self or others.



Pravastatin Sodium Tablets by International Laboratories: Recall - Mislabeling

Thu, 10 Aug 2017 16:00:00 -0400

Common side effects of bupropion include: nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, blurry vision. Risk of allergic reactions are possible and could be life threatening.






Liquid-filled Intragastric Balloon Systems: Letter to Healthcare Providers - Potential Risks

Thu, 10 Aug 2017 11:00:00 -0400

Five reports of unanticipated deaths that occurred from 2016 to present, in patients with liquid-filled intragastric balloon systems used to treat obesity.



Liquid Drug Products Manufactured by PharmaTech and Distributed by Rugby Laboratories and Possibly Other Companies: FDA Advisory - Not to Use

Tue, 08 Aug 2017 00:00:00 -0400

Advisory due to Burkholderia cepacia contamination and the potential for severe patient infection.



Balguti Kesaria Ayurvedic Medicine: FDA Warning - High Levels Of Lead

Fri, 04 Aug 2017 17:25:00 -0400

Exposure to lead can cause serious damage to the central nervous system, the kidneys and the immune system.



System CS100, CS100i and CS300 Intra-Aortic Balloon Pumps by Datascope: Field Correction - Potential Electrical Test Failure Code

Fri, 04 Aug 2017 12:17:00 -0400

UPDATED 08/04/2017. Class I Recall issued. Risk of failure of the device to initiate therapy.



Compounded Curcumin Emulsion Product for Injection by ImprimisRx: FDA Investigation - Serious Adverse Events Associated with Use

Fri, 04 Aug 2017 11:30:00 -0400

Drug products, including FDA-approved products, containing polyethylene glycol castor oil have been associated with severe and sometimes fatal hypersensitivity reactions.



Diocto Liquid and Diocto Syrup by Rugby Laboratories: Recall - Possible Product Contamination

Thu, 03 Aug 2017 13:10:00 -0400

Use could result in serious or life-threatening infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.



Man of Steel 1 and Man of Steel 2: Recall - Undeclared Drug Ingredient

Mon, 31 Jul 2017 13:20:00 -0400

Use of product found to contained undeclared Sildenafil could result in death. The groups affected include men with diabetes, high blood pressure, high cholesterol, or heart disease.



0.9 Percent Sodium Chloride Injection by ICU Medical: Recall - Presence of Particulate Matter

Mon, 31 Jul 2017 12:00:00 -0400

Injection of particulate matter could potentially lead to limited adverse events such as allergic reactions, local irritation and inflammation in organs or tissues, or other serious adverse health consequences.



Compounded Triamicinolone and Moxifloxacin Product for Intravitreal Injection by Guardian Pharmacy Services: Alert to Health Professionals - Serious Adverse Events Reported

Fri, 28 Jul 2017 16:20:00 -0400

Patients had diminished visual function and adverse reactions after injection into the vitreous of the eye at the end of the cataract surgery procedure.



Cyclobenzaprine HCl and Amantadine HCl by Apace Packaging: Recall - Potential Mislabeling

Fri, 28 Jul 2017 10:45:00 -0400

Unintentional dosing with Cyclobenzaprine HCl may potentially lead to the development of life-threatening serotonin syndrome, and other serious adverse events.



Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance

Tue, 25 Jul 2017 18:44:00 -0400

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.



La Bri's Body Health Atomic and Xplode Capsules by EZ Weight Loss TX: Recall - Undeclared Drug Ingredient

Tue, 25 Jul 2017 15:00:00 -0400

Sibutramine is known to increase blood pressure and/or pulse rate in some patients and may present a risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.



Super Panther 7K by Ultra Shop Supplement: Recall - Undeclared Drug Ingredients

Mon, 24 Jul 2017 10:30:00 -0400

Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE-5 can lead to fatal cardiovascular collapse.



Penumbra 3D Revascularization Device by Penumbra: Class I Recall - Wire Material May Break or Separate During Use

Fri, 21 Jul 2017 11:25:00 -0400

Fractured pieces of the delivery wire could be left inside the patient’s brain bloodstream. This or the attempts made to retrieve the fractured pieces can lead to serious adverse health consequences.