Articles Posted in FDA/Voluntary Recalls

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The FDA has announced the recall of single capsule packet RegenErect, as it has been discovered that an active drug ingredient is not listed on the label.
Labeled as a dietary supplement, it has been determined that RegenErect contains Tadalafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). Use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Erectile Dysfunction is a common problem in men with these conditions, and as such, consumers may seek these types of products to enhance sexual performance.
RegenErect has been sold over the internet to consumers in the United States of America and Puerto Rico, and given as samples at public events. It is a blue capsule, and sold individually in foil packets with a UPC code of 816860010055.

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A recall has been announced of seven lots of Norgestimate and Ethinyl Estradiol Tablets, due to a packaging error, causing the possibility for the pills to be out of sequence.

The affected pills are the Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg. It has been determined that the blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation. This has additionally caused the lot number and expiration date to be visible only on the outer pouch.

This product is used as an oral contraceptive indicated for the prevention of pregnancy. Though the packaging defect does not pose a health risk, the packaging error can cause the daily regimen to be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.

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The FDA has announced today the recall of Vagifresh Ball and Vagifresh Gel. An analysis by the FDA has found that Vagifresh Gel contains benzocaine, an active ingredient for many anesthetic drug products. An analysis of Vagifresh Ball found the product to contain bacteria including Staphylococcus lentus, S. sciuri, Bacillus Lantus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicid, Gemella spp, and Leuconostoc spp.

The FDA has further determined that marketing material for these products contained unsubstantiated therapeutic claims related to various gynecologic conditions that could have caused women taking these products from seeking appropriate medical care for potentially serious medical conditions.

These products, marketed as cosmetics, are applied by inserting deeply into the vagina for a prolonged period of time. Sold in herbal stores, beauty shops, drug stores, the internet, and by mail order. These two products were also sold under the mixed package named Female One, which contained Vagifresh Ball, Vagifresh Gel and Vagifresh Liquid, though this recall does not involve Vagifresh liquid.

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American Regent has recalled seven lots of injectable dexamethasone sodium phosphate because the agent may form particulates before its labeled expiration date. The recall involves 30-mL multiple dose vials at 4 mg/ml.
American Regent was silent on the issue of whether there have been any injuries or problems reported from this injectable steroid. This can mean they don’t want to say or it can mean absolutely nothing. But the best thing to do is to just tell us from jump street whether anyone has reported injuries and whether those injuries were significant. Because if we are taking a drug or using a product, it is something we really want to know.

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Here are this week’s stories:

  • Vioxx: See Shearlings Got Plowed for a quick summary of the Australian Vioxx trial. Good news.
  • Defibrillator Battery Recall: 5,418 battery packs used in Lifeline AED and ReceiveR external defibrillators are recalled. See the FDA’s notice.
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Lettuce-05-13-10.jpgThe new romaine lettuce recall is the latest in a series of dangerous fruits and vegetables. The impact of clean agricultural practices first really hit public consciousness in 2006 with the massive E.Coli outbreak in Dole spinach. And then in 2008 with the tomato recall. And then in 2009 with the peanut butter recall.

Now, the FDA is telling us that Freshway Food’s bagged romaine lettuce, potentially with sell by (not use by) dates of May 9 and May 10 can contain e.coli O145, which is harmful. The outbreak has likely harmed at least 19 people in Michigan, Ohio and New York. The FDA believes a farm in Yuma Arizona may be the source. Injuries include hospitalizations and hemolytic uremic syndrome (a disease that destroys red blood cells, and may be indicated by bloody diarrhea and acute kidney failure). Adults typically recover quickly, but it can be life threatening to children, the elderly, and people with impaired immune systems.

The lettuce at issue was sold to wholesalers, food service outlets and some stores with salad bars or delis, and may include pre-packaged salads from Kroger, Giant Eagle, Ingles Markets, and Marsh stores. Other states where the salad was sold include Alabama, Connecticut, the District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, West Virginia and Wisconsin. Importantly, Freshway Foods does not produce prepackaged salads for supermarket sales.

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The FDA Law Blog has a great post on the recent Baxter Colleague Infusion Pump Recall. They outline the authority the FDA is using to demand the recall (it is based on a consent agreement entered some years back between Baxter and the FDA after continued pump problems). The FDA Law Blog questions whether Baxter is required to refund purchase prices or reimburse for current pump values. There’s an interesting calculation of Baxter’s expected loss (though, Baxter is hoping to be able to replace the Colleague pumps with other Baxter pumps).
See our prior post on the Baxter pump recall here.

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Boston%20Scientific%20ICD%202-03-16-10%29.JPGHeart devices and the companies that manufacture them have had a rocky road the past few years (excluding Medtronic’s failed sprint fidelis leads: despite needlessly shocking patients, claims for injuries have been found by a federal trial court to be preempted). These include Guidant, which was subject recall and numerous lawsuits over its defibrillators because of a short-circuiting problem.

Now, Boston Scientific (which acquired Guidant in 2006) has voluntarily recalled all (non-implanted) implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). An ICD is a device that monitors heart rhythms and delivers life-saving shocks if dangerous rhythms are detected. A CRT-D treats certain types of heart failure by coordinating the pumping of the heart’s ventricles. The units recalled fall under the COGNIS, CONFIENT, LIVIAN, PRZM, RENEWAL, TELIGEN and VITALITY lines.

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Some interesting news to follow this week:

  • Vioxx: The Pop Tort reports on how “lawsuits played a key role unearthing documents showing what lengths Merck went to cover up mounting evidence that patients taking Vioxx were experiencing a high number of heart attacks and strokes.” Now, Vioxx manufacturer Merck settles some shareholder lawsuits, and includes some proactive measures to protect against these abuses in the future.
  • Medical Radiation: Much continues to be written about radiation as it relates to diagnostic procedures, especially in the wake of the FDA’s newest guidelines. The Mass Tort Defense Blog opines that plaintiffs’ lawyers seeking medical monitoring for their patients may do more harm than good on the basis that it will increase radiation exposure. There is some logic to this, but shouldn’t patients be the ones to choose?