Pharmaceutical Lawsuit and Recall Information
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Johnson & Johnson Pulls Medical Devices In a warning letter dated December 8th, federal health regulators warned Johnson & Johnson’s DePuy Orthopaedics unit that several of its hip, knee and joint replacements were improperly marketed. In response to the FDA’s warning, DePuy has decided to stop selling all if its custom fitted devices. In its [...]
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 [...]
Last month, the FDA approved Boston Scientific’s Promus Element Heart Stent, a tiny tubular device designed to open diseased arteries. Interestingly, the agency issued its approval of the device, even after receiving reports that the stent could potentially become deformed after it is implanted. The problem, officially known as longitudinal stent deformation, also occurs in [...]
The U.S. Food and Drug Administration announced this week that it will conduct a complete safety review of the drug, Pradaxa (dabigatran), following reports that it may cause excessive bleeding. Pradaxa is an oral direct thrombin inhibitor that is used to prevent stroke in patients suffering from nonvalvular atrial fibrillation. The FDA’s safety review announcement [...]
In an online news article posted to Bloomberg’s website this week, it seems that pharmaceutical giant, Bayer AG, could have misled women regarding the potential health risks associated with use of their newer generation of birth control pills. According to information collected from the review of internal company e-mails, Bayer may have even sought to [...]
According to a press release issued by the U.S. Food and Drug Administration, Kimberly-Clark has announced a product recall of a limited number of its Kotex Natural Balance Unscented Tampons Regular Absorbency that were distributed to specific retail stores within the United States. The tampons included in the recall were manufactured with a raw material [...]
Earlier this week, the U.S. Food and Drug Administration issued a warning letter to drug-maker, GlaxoSmithKline, citing several manufacturing violations found during a March 2011 inspection of the company’s drug-manufacturing plant in the United Kingdom. More specifically, federal regulators say the company failed to establish proper procedures that would prevent the microbiological contamination of their [...]
With Halloween fast approaching, the FDA has this week released a consumer safety warning regarding costume contact lenses. The agency is reminding the public that while over-the-counter fashion lenses may enhance the holiday fun, they are dangerous and could potentially lead to serious vision-threatening problems. According to federal regulators, contact lenses are medical devices that [...]
According to a new warning issued last week by the U.S. Food and Drug Administration, GlaxoSmithKline’s popular drug, Zofran, which is used to treat nausea caused by chemotherapy, has been reported to trigger serious and potentially life-threatening changes in heart rhythms. In its warning, the FDA explained that Zofran, otherwise known as ondansetron, can increase [...]
