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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]
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.
The Food and Drug Administration (FDA) issued a Class II recall of more than 7,100 bottles of the antidepressant duloxetine due to the possible presence of a carcinogen. Duloxetine belongs to a ...
The Food and Drug Administration has announced a recall for thousands of bottles of the antidepressant duloxetine, sold under brand names like Cymbalta, due to the presence of a chemical that can ...
Diversion, abuse, and a relatively high rate of overdose deaths in comparison to other drugs of its group. This drug continues to be available in most of the world including the US, but under strict controls. Terfenadine (Seldane, Triludan) 1997–1998 France, South Africa, Oman, others, US Prolonged QT interval; ventricular tachycardia [2] [3]
(Reuters) - The U.S. Food and Drug Administration (FDA) on Friday said it had identified the recall of B. Braun Medical Inc's medicine-delivering pump system as most serious.
The European Medicines Agency defines terms in its Guideline on good pharmacovigilance practices (GVP): [5] Adverse drug reaction is effects arising when drug given even in therapeutic dose either immunologically mediated reaction or pharmacologically mediated adverse response or idiosyncratic reaction due to the peculiarities of individual.
In medicinal chemistry, the term "contamination" is used to describe harmful intrusions, such as the presence of toxins or pathogens in pharmaceutical drugs. [1] The following list encompasses notable medicine contamination and adulteration incidents.