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On 9 November 2012, Indian drugmaker Ranbaxy Laboratories Ltd. voluntarily recalled 10-, 20- and 40-mg doses of its generic version of atorvastatin in the United States. [ 133 ] [ 134 ] [ 135 ] The lots of atorvastatin, packaged in bottles of 90 and 500 tablets, were recalled due to possible contamination with very small glass particles similar ...
Cerivastatin (INN, [1] brand names: Baycol, Lipobay) is a synthetic member of the class of statins used to lower cholesterol and prevent cardiovascular disease.It was marketed by the pharmaceutical company Bayer A.G. in the late 1990s, competing with Pfizer's highly successful atorvastatin (Lipitor).
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]
Was available through a restricted access program until April 2008; returned to market in 2019. Temafloxacin: 1992 Germany, UK, US, others Low blood sugar; hemolytic anemia; kidney, liver dysfunction; allergic reactions [2] [3] Temafloxacin: 1992 US Allergic reactions and cases of hemolytic anemia, leading to three patient deaths.
The American Heart Association recently updated its risk equations for predicting the risk of cardiovascular disease events, which means that millions of Americans may soon no longer qualify for ...
ATC code C10 Lipid modifying agents is a therapeutic subgroup of the Anatomical Therapeutic Chemical Classification System, a system of alphanumeric codes developed by the World Health Organization (WHO) for the classification of drugs and other medical products.
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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.