Category: MedWatch Safety Alerts
Classic Zi Xiu Tang Bee Pollen Capsules And Ultimate Formula Capsules by Zi Xiu Tang Success: Recall – Undeclared Sibutramine
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. MedWatch Safety Alert RSS Feed
Ameridose, LLC: Recall of Unexpired Products in Circulation
FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility. MedWatch Safety Alert RSS Feed
Hospira Symbiq Infusion System Touchscreen: Class 1 Recall – May Not Respond to Selection
Failure of touchscreen to respond to user input could result in a delay or interruption in therapy or over delivery or under delivery of medication. MedWatch Safety Alert RSS Feed
Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall – User Difficulty With Firing Stapler Devices
Failure to complete the firing stroke of the stapler can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal. MedWatch Safety Alert RSS Feed
Over-The-Counter Eye Drops and Nasal Sprays: Drug Safety Communication – Serious Adverse Events From Accidental Ingestion by Children
Accidental ingestion of active ingredients tetrahydrozoline, oxymetazoline, or naphazoline may cause serious and life-threatening adverse events. MedWatch Safety Alert RSS Feed
Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems: Class I Recall – Flowmeter May Continue To Release Nitrous Oxide Gas When The Oxygen Is Turned Off
When not mixed with oxygen, inhaling nitrous oxide can lead to temporary and permanent brain damage and death. MedWatch Safety Alert RSS Feed
FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised
Healthcare professionals should follow-up with patients administered an NECC injectable product, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution. MedWatch Safety Alert RSS Feed
Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Safety Communication – Reports of Serious Tissue Damage
Incorrect use can cause hemorrhaging and soft tissue, muscle, and vital organ damage, which can lead to serious injury and/or death. MedWatch Safety Alert RSS Feed
Hospira Lactated Ringer’s And 5% Dextrose Injection, 1000 Ml, Flexible Containers: Recall – Mold Contamination
Voluntary Nationwide Recall Of One Lot. Injections of mold could potentially lead to septicemia, which in a worst-case scenario may have the potential to progress to septic shock, which may be life threatening. MedWatch Safety Alert RSS Feed
New England Compounding Center (NECC) Potentially Contaminated Medication: Fungal Meningitis Outbreak
FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate. MedWatch Safety Alert RSS Feed
