King Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer, has voluntarily recalled all dosages of a combination morphine sulfate and naltrexone hydrochloride (Embeda Extended Release Capsules CII) from wholesalers and retailers in the United States because "a prespecified stability requirement was not met during routine testing," a message on the product's Website notes.
Available data suggest that the issue is unlikely to pose a safety risk to patients using the product as prescribed, the company's message to patients and prescribers notes.
"Embeda will not be available until the issue is resolved; while it's too soon to know precise timing, it is likely thatEmbeda will not be available for many months," the company noted in an email to Medscape Medical News. "Pfizer is committed to making Embeda available to physicians and patients as soon as possible once this stability issue is resolved."
Patients can continue taking the product as prescribed, the letter notes, and should not stop taking it without consulting their physician about switching to another opioid. They are advised to explore alternate forms of pain relief with their healthcare provider before coming to the end of their current supply.
"We apologize for any inconvenience that this recall may cause," the company adds.
A spokeswoman for the US Food and Drug Administration, Karen Mahoney, at the Center for Drug Evaluation and Research, said that there are currently multiple extended-release and immediate-release morphine products available on the market. "Therefore, this should not result in a drug shortage," she told Medscape Medical News.
For questions or to report an adverse health consequence or product complaint, patients and providers are asked to call the company's medical information line at 1-800-776-3637.
More information on the recall is available on the Embeda Website.