Pharmaceutical Lawsuit and Recall Information
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Medical Devices Have No Uniform Labeling System The Politico reports, the Food and Drug Administration “has been coordinating with device regulators around the world in a push to develop a uniform code that would be a regulatory relief for an increasingly globalized industry.” The FDA sent a proposal last July to the Office of [...]
Ranbaxy Laboratories Lipitor Bloomberg News (1/26, Gale, Schoenberg) reports, BBC News (1/26) adds. “The legal proceedings do not affect the US sale of Ranbaxy’s generic version of the best-selling drug in the world, cholesterol” medications “Lipitor [atorvastatin].” Moreover, “the filing by the Justice Department on behalf of the FDA must be approved by a [...]
Hospital Reporting Does Not Include All Adverse Events A study released today by the Office of the Inspector General for the U.S. Department of Health and Human Services suggests that approximately 86% of adverse events experienced by patients go unreported, never finding their way into the databases of incident reporting systems. The hospital administrators interviewed [...]
Drugmaker, Novartis, has issued a voluntary recall of 1,645 lots of Excedrin, NoDoz, Bufferin and Gas-X Prevention, over concerns that some of the bottles may contain stray prescription pain killers, as well as broken or chipped pills. The Novartis recall affects all Bufferin and Gas-X Prevention products with expiration dates of December 20, 2013 or [...]
Pharmaceutical company, Johnson & Johnson, has agreed to pay the U.S. more than $1 billion in order to settle the civil investigation into the company’s marketing practices of its popular antipsychotic, Risperdal. News of the long-awaited settlement arrives courtesy of sources from Bloomberg News. J&J, one of the world’s largest makers and distributors of health [...]
FDA Warning For Transvaginal Surgical Mesh The U.S. Food and Drug Administration has issued a warning regarding the post-surgical risks associated with transvaginal surgical mesh, which is often implanted in women to repair weakened or damaged tissue, as well as to provide support in cases of pelvic organ prolapse (POP). This type of surgical mesh [...]
The FDA is taking time to warn pharmacists about potential dispensing errors that could occur as a result of a mix-up between 2 drugs with very similar brand names. Confusion over the two medications could cause patients to be given the wrong prescription and subsequently endure serious injuries. The two brands in question are Durezol [...]
Almost 11 years ago, the U.S. Food and Drug Administration sent an agency investigator to France in order to inspect a plant run by breast implant manufacturer, Poly Implant Prothese (PIP). After the inspection was completed, U.S. health authorities issued a warning letter to PIP’s founder in June of 2000, outlining more than 10 manufacturing [...]
The results of a new study have revealed that recent technology for artificial hips and keens did not perform any better than older, less expensive designs. The study, which was published this week, utilized data collected from Australia’s orthopedic registry and encompassed information on implants introduced between the years 2003 and 2007. The findings were [...]
Japanese drug maker, Daiichi Sankyo, announced that its Indian unit, pharmaceutical giant, Ranbaxy Laboratories, Ltd., had reached an agreement with the U.S. Food and Drug Administration regarding its manufacturing practices. The company’s settlement with the FDA outlines its intent to improve procedures and policies in its production facilities in order to ensure data integrity and [...]
