King Pharmaceuticals Recalls Embeda

Karen Lee Richards Health Guide
  • On March 10, 2011, King Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc., voluntarily recalled all dosage forms of Embeda® (morphine and naltrexone) extended release capsules from U.S. wholesalers and retailers.  According to King, a pre-specified stability requirement was not met during routine testing.

    Based on available data, King says that Embeda is unlikely to cause adverse health consequences to patients using it as prescribed by their physicians.  If you are currently taking Embeda, do not abruptly discontinue its use due to the potential for serious adverse events, such as withdrawal.  However, be sure to consult with your doctor about an alternate treatment before you run out of your current prescription.

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    Embeda will not be available until the stability problems have been resolved.  At this time, King does not have an estimate of how long that will take, but they do say it is likely that Embeda will not be available for “many months.” 

    Embeda received FDA approval in August of 2009 for the treatment of moderate to severe chronic pain. 

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    Source:
    King Pharmaceuticals Inc., voluntarily recalls EMBEDA. American Chronic Pain Association.  March 11, 2011.

Published On: March 14, 2011