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FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
Levetiracetam, sold under the brand name Keppra among others, is a novel antiepileptic drug [7] used to treat epilepsy. [8] It is used for partial-onset , myoclonic , or tonic–clonic seizures, [ 7 ] and is taken either by mouth as an immediate or extended release formulation or by injection into a vein .
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
The U.S. Department of Health and Human Services (HHS) announced an immediate pause on public communications from federal health agencies in January. The pause, ordered by the Trump administration ...
Gilead Sciences Inc. (NASDAQ:GILD) has voluntarily recalled one lot of its COVID-19 treatment, Veklury (remdesivir), for Injection 100 mg/vial, after discovering glass particles in the vials. The ...
The FDA is advising consumers not to use these 27 eye drop products after uncovering unsanitary conditions at a manufacturing facility.
Keppra (levetiracetam) – an anticonvulsant drug which is sometimes used as a mood stabilizer and has potential benefits for other psychiatric and neurologic conditions such as Tourette syndrome, anxiety disorder, and Alzheimer's disease; Klonopin – anti-anxiety and anti-epileptic medication of the benzodiazepine class
FDA has issued emergency authorizations for a range of Covid-19 tests as well as for hydroxychloroquine, a malaria medicine with limited evidence suggesting it can fight the coronavirus.