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The list of 1997 drug labelling changes can be found on the FDA's website, here. The first patient package insert required by the FDA was in 1968, mandating that isoproterenol inhalation medication must contain a short warning that excessive use could cause breathing difficulties.
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.
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 FDA has recalled thousands of bottles of the antidepressant duloxetine, sold under brand name Cymbalta, due to the presence of a possibly cancer-causing chemical.
More than 233,000 bottles of an antidepressant have been recalled by public health officials due to a chemical containing the risk of cancer.. The U.S. Food and Drug Administration classified ...
An Endo, Inc. spokesperson provided a statement about the recall. "Our first priority at Endo is the quality and safety of our products and well-being of patients," Linda Huss said in a statement ...
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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 ...