Safety Alert: Voluntary Recall
Tuesday, March 15th, 2011
King Pharmaceuticals Announces a Voluntary Recall of Embeda Extended Release Capsules
King Pharmaceuticals Inc., a wholly owned subsidiary of Pfizer, voluntarily recalled all dosage forms of the extended release capsules of morphine sulfate with naltrexone hydrochloride (Embeda) from U.S. pharmaceutical wholesalers and retailers on March 10, 2011. This long-acting pain medication is used for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
The reason for the voluntary recall is that one of the pre-specified stability requirements was not met during routine testing. Available data currently suggests that requirement is not likely to cause adverse health consequences to individuals who are taking this pain reliever as prescribed by their health care provider. King reports that it will continue to monitor this issue. In the meantime this medication will not be available to the marketplace until the issue is resolved, which may take several months.
People with pain can continue taking their current Embeda prescription as directed by their health care provider and should not suddenly stop taking the medication to avoid withdrawal symptoms.
Signs of withdrawal are:
| Early symptoms | Later Symptoms |
| Agitation; anxiety | Abdominal cramping |
| Increased tearing or watery eyes | Goose bumps |
| Muscle aches | Nausea/vomiting |
| Rapid heart rate | Small (dilated) pupils |
| Running nose | Diarrhea |
| Sweating | |
| Trouble getting and staying asleep (insomnia) | |
| Yawning |
Individuals who have this medication in their possession should:
- Notify the health care provider who writes your pain medicine prescriptions before your current prescription runs out. Talk about options for new pain medications or treatments.
- Notify your insurance provider should a new prescription be written, so that it will be covered.
- Contact the pharmacy where this medication was filled and report that you are in possession of this recalled medication. Ask for directions if you wish to turn in your recalled supply.
- For any additional medical questions, please call the company at (800) 776-3637.
- Contact the U.S. Food and Drug Administration (FDA) and report any negative experiences. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Online: http://action.painfoundation.org/site/R?i=unipdMMtbRb55IyH1Y9MFw..