North Coast Medical Inc. issued a recall on its Norco Folding Shower Bench due to a design flaw that leads to a risk of falling. The Norco Folding Shower Bench features a nonskid surface and handholds for added security. It also features sturdy legs with non-skid rubber feet. The bench is said to supports up to
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No Comments » On April 23, 2012 the U. S. Food and Drug Administration posted a recall on Biomet’s Selex M2A Magnum Modular Head, 40 mm head diameter plus 3 mm neck, 1 taper. The recall was initiated because devices with a specification for +6mm neck length were incorrectly labeled for a +3mm neck length specification. The Selex
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Hospira, Inc. recalled one lot of Morphine Sulfate Injections USP,1mL fill due to a customer report that two of these syringes contained more than the 1mL labeled fill volume. Administration of an increased volume can lead to an overdose and potentially death. The affected product is a prefilled glass cartridge for use with the Carpuject™
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On April 19, 2012 XROCK Industries LLC recalled all boxes of X-Rock for Men, a dietary supplement to support male sexual performance. The recall was issued after findings of a potentially hazardous ingredient within the supplement. Tests conducted by the Food and Drug Administration (FDA) of X-ROCK for Men concluded that the products contained sildenafil
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Bayer will pay at least $110 million to settle about 500 lawsuits wherein plaintiffs allege that Yaz/Yasmin birth control pills caused serious injuries of which Bayer knew, or should have known, and failed to warn, reports Bloomberg. Bayer officials agreed to pay an average of about $220,000 a case to resolve claims in involving fatal
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On April 11, 2012, the U.S. Food and Drug Administration (FDA) announced changes to the professional labels for Proscar, a medication used to treat symptoms of enlarged prostate and Propecia, a medication used to treat hair-loss. The revised labels for these drugs, which both contain finasteride as the active ingredient, will expand the list of adverse
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Bloomberg News reported that Johnson & Johnson marketed the Gynecare Prolift mesh device in March 2005, touting it as an “innovative and effective surgical option” for weakened pelvic muscles. However, the U.S. Food and Drug Administration (FDA) did not clear the Gynecare Prolift mesh until May 2008, after Johnson and Johnson sought approval for a
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In February, Wright Medical Technology recalled over 5,300 Dynasty Biofoam Shell devices after learning that debris from the packaging spacer can be unintentionally implanted into a patient and can potentially lead to complications that might necessitate a revision surgery. Wright’s Dynasty Biofoam Shell devices are used as hip acetabular shells. The recall affects sixteen different sized devices:
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The U.S. Food and Drug Administration (FDA) has completed its review of studies involving drospirenone-containing birth control pills, such as Yaz and Yasmin and has concluded that these types of birth control pills increase the risk for dangerous blood clot. As a result, the FDA is requiring a label change to include this information. The revised
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Levaquin (fluoroquinolone) has been linked to an increased risk of retinal detachment according to a recent study published in The Journal of the American Medical Association. Retinal detachment, which starts as the appearance of lines, dots or “floaters” across the eye, can cause permanent blindness if it is not surgically treated within a few days.
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