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The events that led to the approval of Colcrys, the clearance of the illegally sold non-FDA approved colchicine products, Colcrys pricing, and the sale of URL Pharma still are controversial today. Before the Colcrys approval, unapproved colchicine products were being illegally sold in the United States for under 10 cents a pill.
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity. The FDA defines an FDA warning letter as:
In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize its ...
Costco is recalling packages of salmon over concerns they could be contaminated with listeria.. Acme Smoked Fish Corp, the shopping club's salmon provider, sent a notice to Costco shoppers this ...
When the product went on sale, 1 million gallons of Vine-Glo were sold with eight wine-flavored varieties created in the first financial year. [1] The product was sold across the United States. When Fruit Industries were trying to launch the product in Chicago in 1930, they published a statement saying that Al Capone had threatened to force ...
The 12 new warnings, showing photos of negative effects of smoking, like mouth cancer, impotence and gangrene are rotated every two years, [72] and on 3 November 2016, all cigarette packaging without graphic health warning messages are banned from sale. [71]
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