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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]
In October 2018, Akorn received Abbreviated New Drug Application (ANDA) approval from Food and Drug Administration (FDA) for Bimatoprost Ophthalmic Solution, 0.03%. [ 7 ] On May 21, 2020, Akorn filed for Chapter 11 bankruptcy and entered in to a Restructuring Support Agreement with lenders, which represents over 75 percent of its secured debt.
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]
The FDA tested the products and found that they had been contaminated with microbes and were not sterile. “Under the Federal Food, Drug and Cosmetic Act, eye drops must be sterile to be safe for ...
The U.S. Food and Drug Administration (FDA) shared the recall last week. According to the FDA’s notice, Neild Med received 11 reports from customers about an “unpleasant odor” coming from ...
The Food and Drug Administration (FDA) announced a nationwide recall of a popular single-use eye drop on December 23. Alcon Laboratories, maker of Systane eyedrops, voluntarily recalled one lot of ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
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 ...