Recalls are actions taken by a company to remove a product from the market. Recalls may be conducted on a company’s own initiative, by FDA request, or by FDA order under statutory authority. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

A market withdrawal occurs when a product has a minor violation that would not be subject to FDA legal action. The company removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

Speak to a Lawyer

Each year, thousands of people die from or are seriously injured by prescription drugs, over-the-counter drugs and medical devices they believe to be safe. If you or a loved one have taken a defective drug, experienced problems with a defective medical device or used a defective product, then contact our law firm immediately. Consult an attorney privately to learn your legal rights. All information is held in the strictest of confidence.

Contact a Drug Lawsuit Lawyer & Attorney

For a free and confidential consultation, fill out our online case evaluation form or call us toll free at: 1-800-883-9858.

Contact an Attorney

Legal help: Contact an Attorney

Ethicon Mesh Recall

In June of 2012, the Ethicon, Inc. division of Johnson & Johnson notified the US Food and Drug Administration that it would no longer be offering some of its Gynecare Women’s Health Mesh products. Although this Ethicon mesh recall was voluntary and not mandated by the FDA, Johnson & Johnson will also case to commercialize these products. They will also be notifying physicians and patients in order to allow them the opportunity to select other treatment options. The four products impacted by this mesh recall decision by Ethicon are the following:

  • Ethicon Gynecare Prolift Pelvic Floor Repair System
  • Ethicon Gynecare TVT Secur System
  • Gynecare Prosima Pelvic Floor Repair System
  • Gynecare Prolift+M Pelvic Floor Repair System

Ethicon Mesh FDA Warning

These decisions by Ethicon to recall the advertisements and offering of these mesh products comes following several warnings from the FDA regarding the increased risk of complications associated with the transvaginal use of surgical mesh. As early as 2008, the FDA warned about vaginal mesh following a large number of adverse event reports in the time period between 2008-2007. However, from2008-2010, there were an even larger number of incidents reported. When the US Food and Drug Administration compiled literature regarding Ethicon and other brands of mesh using data from 1996-2011, they were able to conclude that complications from vaginal mesh are NOT RARE and mesh products were deemed an area of ongoing concern.

Ethicon Mesh Recall Lawsuits

The victims of Ethicon Mesh injuries often choose to pursue litigation against the manufacturer of their particular device. At present there is both state and federal level litigation pending against Johnson & Johnson’s Ethicon, Inc. Additionally, mesh recall lawsuits are pending against several other manufacturers as well, including C. R. Bard, Boston Scientific, and American Medical Systems. Many of these mesh lawsuits were filed after the FDA declared that transvaginal mesh did not appear to provide any benefits for patients that would justify the increase in risk and complications.

File an Ethicon Mesh Recall Lawsuit: Attorney Consultation

Have you experienced mesh erosion or other serious injury following treatment with an Ethicon mesh implant? If so, contact the Willis Law Firm today for a free and confidential recall lawsuit consultation. We know that these are potentially embarrassing women’s health issues, so we have female consultants available for your comfort. Currently, we are assessing Ethicon lawsuit claims in all fifty states, and all mesh clients are represented on a fee contingent basis. If we don’t recover for you, you don’t have to pay any legal or attorney’s fees.

FDA NEWS RELEASE

 

For Immediate Release: Nov. 19, 2010
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Xanodyne agrees to withdraw propoxyphene from the U.S. market

Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne’s decision and requested that they voluntarily remove their products as well.

The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.  

“The FDA is pleased by Xanodyne’s decision to voluntarily remove its products from the U.S. market,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). “These new heart data significantly alter propoxyphene’s risk-benefit profile. The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”

The FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.

Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxophene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).

Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.

In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug’s cardiac effects would be relevant in weighing its risks and benefits.

In June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union. A phased withdrawal of propoxyphene is underway.

In July 2009, the FDA decided to permit continued marketing, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. In addition, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.

The agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.

“With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER. “However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away.”

Xanodyne is based in Newport, Ky.

Morristown, NJ – Further to its previously announced voluntary recall of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches, Actavis is encouraging consumers to return any product in their possession from the October 21, 2010 recall.

Consumers with Actavis 25 mcg/h Fentanyl patches may call 1-877-422-7452 (24 hours/day, 7 days/week) for return instructions and information.

Actavis identified one lot of 25 mcg/hour Fentanyl patches (Control/Lot # 30349) shipped to market that contained one patch that released its active ingredient in laboratory testing faster than the approved specification. An accelerated release of Fentanyl from a 25 mcg/hour patch could lead to adverse events for at-risk patients such as children and the elderly, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing).

The Control/Lot number appears on the bottom of the product box and on the black and white side of each individual patch packaging, in the lower left corner.

Recalled Control/Lot #s

    30041, Exp 12/2011
    30049, Exp 12/2011
    30066, Exp 12/2011
    30096, Exp 01/2012
    30097, Exp 02/2012
    30123, Exp 01/2012
    30241, Exp 02/2012
    30256, Exp 02/2012
    30257, Exp 03/2012
    30258, Exp 03/2012
    30349, Exp 03/2012
    30350, Exp 03/2012
    30391, Exp 03/2012
    30392, Exp 04/2012
    30429, Exp 04/2012
    30430, Exp 04/2012
    30431, Exp 04/2012
    30517, Exp 04/2012

Corium International Inc., a third-party supplier for Actavis, manufactured the recalled patches at its Grand Rapids, Michigan facility. The patches are packaged individually and boxed in quantities of five patches per box.

Fentanyl Transdermal System is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.

As part of the voluntary recall, all wholesalers and retailers were asked to return the product from the listed lots that they may still have on hand or in stock. Actavis also is encouraging consumers to return product in their possession. Fentanyl patches sold by Actavis in Europe are not impacted by the recall.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Information also is available through the Actavis U.S. website at www.actavis.us by going to the “Fentanyl Recall Information” link on the front page.

FDA notified healthcare professionals of a Class I recall of LIFEPAK 15 Monitor/Defibrillator manufactured and distributed between March 26, 2009 and December 15, 2009. There is a potential for the device to unexpectedly:

  • Power Off then On by itself.
  • Power Off then NOT turn On.
  • Power Off by itself requiring the operator to turn it back On.
  • Stay powered On and not allow itself to be turned Off.

Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Stryker and FDA notified healthcare professionals of a recall of 23 Operating Room System II Surgical Navigation Systems because there is a potential for the navigation PC SPC-1 component to stop working which could result in the screen freezing, the system updating at a slow rate, or not responding at all. The Navigation System II is a computer aided surgery platform that surgeons can use to perform Hip, Knee, Spine, Neuro and ENT surgical procedures and contains a computer workstation with the navigation System II software and various components necessary to run the system.The potential harms associated with this failure are: delay in surgery, reschedule of the procedure resulting in an additional surgery, risk of infection, increased morbidity, potential neurological deficits, or injury due to the surgeon operating in an area where they did not intend to operate. Depending on the type of surgery, these failures could potentially lead to serious adverse health consequences, including death. Hospitals that have product that corresponds to the catalog numbers above should immediately quarantine the product, label it as a recalled product and stop using the product.

Cardiovascular Systems, Inc. and FDA notified healthcare professionals of a nationwide recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use.

In the event of a device fracture, separated segments of the device may require unplanned open surgery to remove the retained segments or control bleeding. Since this device is coil reinforced, any separation of the cannula (a flexible tube inserted into the body) has the potential to expose portions of the coil, creating the potential for vessel dissection or perforation.

The recall encompasses products distributed from March 25, 2009 to October 21, 2009, and includes the following lot ranges and catalog numbers:

  • Lot range: S28117 through S29174
  • Catalog numbers: VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 X 45

FDA notified healthcare professionals of a Class I Recall of all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement, a device used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. Reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ at six to fifteen months post implantation were received. Potential adverse health issues that could be associated with this issue include neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and/or need for reoperation/revision surgery. Surgeons and hospitals in possession of the subject devices must stop implanting them immediately. This product was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009.

FDA and Edwards Lifesciences notified healthcare professionals about the Class 1 recall of CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65, a device that blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. The recall was initiated because the balloon catheters may spontaneously rupture during surgery. This product was manufactured from August, 2008 through August, 2009 and distributed from November, 2008 through September, 2009.

Centurion Medical Products and FDA notified healthcare professionals about a Class I recall of Premie Pack, Kit Code LM 110 and Full Term Meconium Pack, Kit Code LM115. The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated on the label, which could result in an inability to remove secretions and cause partial or complete blockage of the airway and the inability to ventilate the patient. These products were distributed from January 1, 2007 through September 22, 2009.

Pointe Scientific and FDA notified healthcare professionals of a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. Distributors and testing laboratories who have received the Liquid Glucose Hexokinase Reagent (G7517) which is being recalled should destroy remaining inventory.

Testing laboratories should consider all test results obtained with the lot numbers listed above to be questionable. The laboratory should inform the patient’s attending physician, and determine, with their input, whether confirmation of the previous test results will be required.