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On August 24, 2010, DePuy recalled [4] all ASR hip implant systems sold since 2003. The 2010 DePuy Hip Recall was issued after research released by the National Joint Registry (NJR) found high rates of hip replacement failure for the ASR XL Acetabular and ASR Hip Resurfacing systems.
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]
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The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
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In 2021, OrthoTrophix, the developer of the drug, reported that a one-year study of 93 patients suggested that TPX-100 treatment was associated with significant and sustained improvements in critical knee functions, preservation of knee cartilage thickness, reduced pathologic changes in the underlying bone, and a >60% decrease in the use of ...
Before the COVID-19 pandemic, Congress highlighted drug safety issues in the wake of recalls of blood pressure drugs contaminated with small amounts of known carcinogens.
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