Recall of Embeda

King Pharmaceuticals recalls Embeda because of unmet requirements

(RxWiki News) King Pharmaceuticals Inc. has voluntarily recalled all dosages of Emeda, a narcotic pain reliever, because of unmet stability requirements during testing.

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. We apologize for any inconvenience that this recall may cause.

For questions, or to report an adverse health consequence or product complaint, please call our Medical Information line at 1(800) 776-3637.

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Review Date: 
March 15, 2011