Recall on Drug – Embeda

Released: 03/21/2011   By: Jennifer Fuqua

King Pharmaceuticals recalls Embeda

Morphine/naltrexone extended-release capsules did not meet stability requirement; will be unavailable for “many months.”

King Pharmaceuticals Inc. announced that a voluntary recall of all dosage forms of Embeda (morphine/naltrexone) extended-release capsules from U.S. wholesalers and retailers. King reported that Embeda did not meet a prespecified stability requirement during routine testing.

Based on available data, this issue “is unlikely to cause adverse health consequences to patients using Embeda as prescribed by their physicians,” wrote Marsha Stanton, PhD, RN, Senior Director of Advocacy and External Affairs at Pfizer, Inc., in a letter to APhA. Pfizer completed its acquisition of King Pharmaceuticals earlier this month.

Embeda is approved for around-the-clock management of moderate to severe pain. Stanton said that patients “can continue taking Embeda as prescribed and should not abruptly discontinue Embeda due to the potential for serious adverse events.” She advised patients to consult with their physician about alternative treatments before they complete their current prescription.

“Embeda will not be available until the issue is resolved,” Stanton reported. She said that King does not know when that will happen, but “it is likely that Embeda will not be available for many months.”

Stanton said that medical questions about this issue can be directed to King Pharmaceuticals at 800-776-3637.

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