Johnson & Johnson Unit Recalls Some Transdermal Pain Patches

The Ortho-McNeil-Janssen unit of drug and consumer giant Johnson & Johnson is voluntarily recalling all of its 25 microgram-per-hour-strength Duragesic pain patches, which the company said have the potential to expose patients to a dangerous gel inside. Duragesic is used to manage persistent moderate to severe chronic pain that needs to be treated around the clock. The patches are sold in the United States by PriCara, an Ortho-McNeil division, and Sandoz Inc.

The company says the recall, conducted in cooperation with the U.S. FDA, affects all lots of its 25 mcg/hr Duragesic CII patches sold in the United States with expiration dates on or before December 2009, because theses patches may have an opening that could result in release of the gel made of the drug fentanyl inside, leading to potentially serious harm.

"Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal," notes a press release from the company on the recall. "Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches with cut edges by flushing them down the toilet, using caution not to handle them directly. Patches with a cut edge that have leaked gel will not provide effective pain relief."

The company says that anyone who has 25 mcg/hr Duragesic or Sandoz Inc. fentanyl patches (fentanyl transdermal system) should check the box or foil pouch for the expiration date to see if they have patches that are being recalled. The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. Affected patches should not be handled directly.

Anyone with 25 mcg/hr Duragesic patches being recalled should call 800-547-6446. Anyone with 25 mcg/hr Sandoz Inc. patches being recalled should call 800-901-7236. Other strength patches (12.5, 50, 75 and 100 mcg/hr) are not affected by this recall, nor are Duragesic patches sold in Europe, Latin America, and Asia, according to the company. For more information, visit www.DURAGESIC.com or http://www.jnj.com/news/.

Download Center

HTML - No Current Item Deck
  • Get the Ultimate Guide to OSHA Recordkeeping

    OSHA’s Form 300A posting deadline is February 1! Are you prepared? To help answer your key recordkeeping questions, IndustrySafe put together this guide with critical compliance information.

  • Steps to Conduct a JSA

    We've put together a comprehensive step-by-step guide to help you perform a job safety analysis (JSA), which includes a pre-built, JSA checklist and template, steps of a JSA, list of potential job hazards, and an overview of hazard control hierarchy.

  • Levels of a Risk Matrix

    Risk matrices come in many different shapes and sizes. Understanding the components of a risk matrix will allow you and your organization to manage risk effectively.

  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Industry Safe
TenCate FR Technology

OH&S Digital Edition

  • OHS Magazine Digital Edition - October 2020

    October 2020

    Featuring:

    • FACILITY SECURITY
      EHS Compliance: Make it Personal
    • FOOT PROTECTION
      Choosing the Right Safety Shoe for Your Industry
    • HAND PROTECTION
      A Requirements Checklists for Work Safety Gloves
    • COVID-19 MANAGEMENT
      Contemporary Issues in HSE Management
    View This Issue