IMPORTANT INFORMATION FOR PATIENTS AND PRESCRIBERS
King Pharmaceuticals Inc., a wholly owned subsidiary of Pfizer, has voluntarily recalled from U.S. wholesalers and retailers all dosage forms of EMBEDA® (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII because a pre-specified stability requirement was not met during routine testing.
Available data suggest that the issue is unlikely to pose a safety risk to patients using EMBEDA as prescribed. We continue to monitor this issue.
Patients can continue taking EMBEDA as prescribed. Patients should not stop taking EMBEDA without consulting their doctor about switching to another opioid medicine. Before patients run out of EMBEDA, they should consult with their health care provider about another treatment for their pain.
Pfizer is committed to making EMBEDA available to physicians and patients as soon as possible once this stability issue is resolved. [Pfizer] apologize[s] for any inconvenience that this recall may cause.
For questions, or to report an adverse health consequence or product complaint, please call [the Pfizer] Medical Information line at 1(800) 776-3637.
DISCLAIMER: The contents of this document are for informational purposes only. It is not a substitute for a medical exam, nor does it replace the need for services provided by a medical professional. The information provided in this document is not intended to diagnose, treat, or cure. Every effort has been made to provide accurate, up-to-date and complete information, but no warranty or guarantee is made to that effect. Healthesystems is not liable for any direct, indirect, consequential, special, exemplary, or other damages arising from the use or misuse of any material or information provided in this document.