Stability problems see Pfizer recall pain drug Embeda acquired in King deal

Within a couple of weeks of finally acquiring King Pharmacueticals for $3.6 billion, global drugs behemoth Pfizer (NYSE: PFE) has been obliged to pull sales of the recently launched opiod painkiller Embeda (morphine sulfate and naltrexone hydrochloride).

On the official web site for Embeda, King said it has voluntarily recalled from US wholesalers and retailers all dosage forms of the drug 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, and the company will continue to monitor this issue.

Embeda, which has annual sales of less than $70 million (compared with $1.8 billion for the King group), was recalled in the USA because of a stability defect found in the extended-release product during routine testing. The drug contains pellets of morphine that surround naltrexone, a chemical which blocks opiate effects if the product is crushed or chewed - thereby deterring misuse or abuse.