FDA Clears First Blood Tracking Device That Uses Radio Frequency Identification Technology
iTrace for Blood Centers, the first application to use Radio Frequency Identification (RFID) technology in blood establishments to assist in enhancing blood safety by preventing the release of unsuitable blood components, was cleared today by the US Food and Drug Administration.
FDA Alerts Regarding Steroid Injections from Main Street Family Pharmacy
The US Food and Drug Administration is working closely with the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn.
USP Injectable Vials by Sandoz US: Recall - Particulate Matter In Vials
Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its methotrexate sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer.
FDA Approves Label Changes for Zolpidem Products
The US Food and Drug Administration (FDA) is notifying the public that FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications.
FDA Releases New Tool to Help Prevent Intentional Food Contamination
The US Food and Drug Administration has released a new tool to help bolster the food industry’s defense measures against an act of intentional food contamination.
FDA Warns Consumers About Potential Health Risk with Juices Inc. Juice Products
The US Food and Drug Administration is warning consumers not to consume any juice products or other beverages from Juices Incorporated (aka Juices International and Juices Enterprises) of Brooklyn, N.Y.
FDA Alert Regarding The Compounding Shop
The US Food and Drug Administration is alerting healthcare providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site.
FDA Issues Proposal to Increase Consumer Awareness of Tanning Bed Risks
Today, the US Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.
Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women
The US Food and Drug Administration (FDA) is advising healthcare professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches.
FDA Limits Duration and Usage of Samsca
The US Food and Drug Administration (FDA) has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially requiring liver transplant or death.