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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 ...
Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs).
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 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 ...
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]
Related: Hundreds of Frozen Waffle Products Recalled Due to Possible Listeria Risk The product was packaged in 32-ounce plastic bottles with a best-by date of February 25, 2025. The FDA has set ...
The recall is applied specifically to the 20-pound carton boxes containing four packages of “Skyline Provisions, Inc. Ground Beef 81/19” with “Item # 000248” printed on the label, as well ...
In 2005, sales were estimated at US$18.7 billion in the United States. [11] The best-selling statin is atorvastatin, also known as Lipitor, which in 2003 became the best-selling pharmaceutical in history. [12] The manufacturer Pfizer reported sales of US$12.4 billion in 2008. [13]