FDA permits marketing of a diagnostic test to aid in the determination of menopausal status
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Statement from FDA Commissioner Scott Gottlieb, M.D., on how new regulatory authorities will assist the agency in more forcefully addressing opioid crisis; included as part of the newly enacted Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act
The SUPPORT Act grants FDA additional authorities to meaningfully advance efforts to combat the crisis of opioid addiction plaguing our nation.
Sirob Imports, Inc. Issues Recall Due to Elevated Lead in Spices
Sirob Imports, Inc of Lindenhurst, NY is recalling, Corrado, Orlando Imports, Nouri’s Syrian Bakery, Mediterranean Specialty Foods Brand and Butera Fruit Market Curry Powder because it contains elevated levels of lead.
FDA approves new drug to treat influenza
FDA approved Xofluza (baloxavir marboxil) to treat acute uncomplicated flu in patients 12 years old and older who have been symptomatic for less than 48 hours.
G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk
G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes
Federal judge enters consent decree against Tennessee over-the-counter drug manufacturer
A federal court orders a Tennessee-based company to stop selling over-the-counter (OTC) drug products
FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids
FDA warns website networks as part of global crack down for selling illegal pharmaceuticals
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths
New Seasons Market Issues Allergy Alert on Undeclared Soy in Hot & Sour Broth
New Seasons Market is recalling 193 jars of New Seasons Market Hot & Sour Broth because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.
Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution
Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials, to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution.