King recalls combination opioid

March 17, 2011

Late last week, King Pharmaceuticals, a subsidiary of Pfizer, voluntarily recalled Embeda (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, a schedule II controlled substance, from all U.S. wholesalers and retailers.

Late last week, King Pharmaceuticals, a subsidiary of Pfizer, voluntarily recalled Embeda (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, a schedule II controlled substance, from all U.S. wholesalers and retailers.

The manufacturer recalled 27 lots of Embeda after a “prespecified stability requirement was not met during routine testing.” The combination opioid will not be available until the issue is resolved, which may take several months, according to a company statement.

Patients who already have Embeda capsules should not abruptly discontinue Embeda because of the potential for serious adverse events. “Available data suggest that it is unlikely to cause adverse health consequences to patients using Embeda as prescribed by their physicians,” according to the company.

However, before their Embeda prescriptions run out, patients should talk to their physicians about appropriate alternate treatments, according to the manufacturer.

The company is investigating the cause of the stability issue. During routine testing, the manufacturer found elevated levels of sequestered naltrexone degradants. “Pfizer is committed to resolving this issue, and making Embeda available to physicians and patients as soon as possible,” according to the statement.