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Methotrexate Injection Recalled Over Glass Flakes

Some lots of Methotrexate Injection 50mg/2mL and 250mg/10mL vials are being recalled today by Sandoz Inc., following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots. Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis.

The recall involves Methotrexate Injection vials sold under the brand names Sandoz and Parenta. The Methotrexate Injection, USP, 50mg/2mL vials included in the recall bear NDC Number 66758-040-02 (10 vial pack) and 66758-040-01 (Individual vial). The Methotrexate Injection, USP, 250mg/10mL bear NDC Number 66758-040-08 (10 vial pack) and 66758-040-07 (Individual vial). A complete list of lot numbers and expiration dates are available here. (more…)

Complications Seen wth Use of Vaginal Mesh

Evidence continues to grow that vaginal mesh products are not the best choice for surgical repair of pelvic prolapse in women. According to a report in The New York Times, a clinical trial of vaginal mesh was halted last year because of the high number erosions seen in patients receiving the mesh.

The halted trial, detailed in the journal Obstetrics & Gynecology, involved 65 women with pelvic organ prolapse. They were randomly assigned surgical repair with the mesh or colpopexy, a traditional procedure that uses the patient’s own ligaments to support the sagging muscles. Thirty-two women underwent mesh colpopexy, and 33 had the standard colpopexy. (more…)

Actavis Fentanyl Pain Patches Recalled

Drugmaker Actavis Inc. is recalling 18 lots of its Fentanyl Transdermal System 25 mcg/hour C-II patches. According to the recall notice, the Fentanyl pain patches may release active ingredient faster than the approved specification. This could lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing). According to the recall notice, Actavis identified one lot of 25 mcg/hour Fentanyl patches shipped to market that contained one patch that released its active ingredient faster than the approved specification in laboratory testing. The company has characterized this recall as a precautionary measure. (more…)

Heart, Diabetes Warning for Prostate Cancer Drugs

Drugs used to treat the symptoms of advanced prostate cancer have been associated with diabetes and heart problems. The US Food and Drug Administration (FDA) has directed the makers of the drugs – called GnRH agonists – to add information about diabetes and heart problems to the Warnings and Precautions sections of the drug’s labels.

GnRH agonists are sold under the names Eligard, Lupron, Synarel, Trelstar, Vantas, Viadur, and Zoladex, and are also available as generic version. (more…)

Massive Graco Stroller Recall After Infant Deaths

Some Graco strollers have killed four children, prompting a massive recall. The recall involves older versions of the Graco Quattro Tour™ and MetroLite™ strollers and travel systems manufactured prior to the existence of the January 2008 voluntary industry standard which addresses the height of the opening between the stroller’s tray and the seat bottom.

According to the Consumer Products Safety Commission (CPSC), entrapment and strangulation can occur, especially to infants younger than 12 months of age, when a child is not harnessed in the recalled strollers. An infant can pass through the opening between the stroller tray and seat bottom, but his/her head and neck can become entrapped by the tray. (more…)

Popular Heartburn Drugs Tied to Heart Birth Defects

If you’re pregnant and taking a proton pump inhibitor – Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, and Aciphex, as well as over-the-counter versions like Prilosec OTC, Zegerid OTC and Prevacid 24HR. – you might want to look for an alternative. A study released in May found that taking proton pump inhibitors during pregnancy could double the risk of a baby being born with a heart birth defect.

The study, conducted by researchers at the University of Pennsylvania, was presented in May at the Digestive Diseases 2010 conference in May. (more…)

CPSC Reissues Recall for Exploding Children’s Aromatherapy Kits

There have been 12 more reports of explosions linked to Spa Factory™ Aromatherapy Fountain & Bath Benefits Kits, prompting the US Consumer Products Safety Commission (CPSC) to re-issue a recall for the children’s kits that was first announced in January 2009. The latest explosions have been linked to 13 new injuries. JAKKS Pacific® Spa Factory™ Spa Fantasy Aromatherapy Fountain & Bath Benefits Kits were sold at Sam’s Club, Walmart, Target, and other stores

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nationwide from August 2008 through August 2010. They sold for between $13 and $50 and continue to be available in some stores. (more…)

Settlement Breakthrough Announced in Chinese Drywall Lawsuits

There’s been a big breakthrough in the litigation involving Chinese drywall. A settlement announced yesterday involving Knauf Plasterboard Tianjin Co. could eventually lead to resolution of thousands of cases.

Under the proposed settlement, Knauf, along with a group of builders and suppliers, will pay to remediate 300 homes in Florida, Mississippi, Alabama and Louisiana. The remediation program will follow guidelines established by the Consumer Products Safety Commission, which call for the removal of the tainted drywall, ad for replacements made for electrical wiring, appliances including air conditioning, and fixtures damaged by drywall fumes. In addition, homeowners under settlement will receive $8.50 per square foot to cover any additional expenses such as moving costs and temporary housing. (more…)

Botox Settlements Reported

Botox, best known as a wrinkle eraser, has been in the news quite a bit of late, but not for anything good. Most recently, Allergan, the maker of Botox, admitted it had illegally promoted the drug for off-label uses. The company has also faced lawsuits over Botox side effects, one of which it recently settled out-of-court.

Allergan pleaded guilty to the marketing charges in settlement agreement with the US Justice Department last month. Federal prosecutors launched the investigation into Allergan when two whistle blowers – a physician and a Botox sales representative – filed a complaint in Atlanta. The company was accused of making it “a top corporate priority to maximize sales of Botox” for unapproved uses between 2000 and 2005, according to documents released by the Justice Department. As part of the plea agreement, Allergan will pay penalties of $600 million. (more…)

Massive Wrongful Foreclosure Probe Set

A group of state attorneys general are launching a joint investigation into the mortgage foreclosure mess. The probe, which will be led by the Iowa attorney general, will involve as many as 40 states.

According to a report in The Wall Street Journal, the first goal of the attorneys general wrongful foreclosure investigation will be to determine the scale of the document problems and correct them. However, some want the investigation to go beyond the robo-signing issue. For example, Arizona’s attorney general said he would like the probe to look into foreclosure proceedings that occur while homeowners are engaged in the modification process with their banks. (more…)

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