Sandoz recalls morphine from across Canada

None of mislabelled ampoules found or used in Montreal, hospitals confirm

Sandoz Canada Inc., is voluntarily recalling 57,000 vials of injectable morphine over a packaging mix-up that carried a potentially significant health risk.

The Quebec drug company, already at the centre of a drug shortage crisis, is now facing a new public relations problem after a Toronto hospital discovered four vials of a heart drug called isoproterenol hydrochloride – an adrenalin-like drug used in cases of cardiac arrest – inside a package of injectable morphine.

Hospitals across the country were told to immediately quarantine 2-mg/ml ampoules of morphine sulphate injection from the affected lot. Sandoz will recall all 57,000 vials of the morphine that went out to hospitals. It will conduct a “100 per cent” visual inspection of some 103,000 vials that remain in its inventory before releasing any of the morphine to hospitals.

The recall affects Sandoz’s second-highest-selling format of morphine.

A packaging error with such a significant health risk is extremely rare, according to Health Canada.

On Thursday, Sandoz advised Health Canada that its lab tests confirm that the vials themselves were properly labelled – meaning that the right drugs were in the right vials.

Health Canada has not received any reports of patient harm involving the pack- aging mixup. The recalled morphine will not be re-released.

On Wednesday, Sandoz could not confirm whether there were other similarly mislabelled boxes in hospitals and by midday Thursday the company still was not taking media calls, saying only via email that a statement would be issued.

“To date we’ve only had one report of one (mislabelled) package,” Dr. Robert Cushman, director general of biologic and genetic therapies at Health Canada, told Postmedia News. “There may be more but, to date, one, and maybe only one.”

He said the isoproterenol may have ended up in the package of morphine when the production line switched over.

“It looks like the last four vials that went into one of these 10-packs – it’s about the size of a cellphone-and-a-half – were isoproterenol and not morphine,” Cushman said.

The vials have different colour-coding and print, and Cushman said that health professionals make a series of checks “all along the chain” before a drug is administered to a patient.

“The next step is to make sure that these medications get out of the packages and get double-checked,” he said.

“The good news is that most of the lot still remains in Sandoz’s inventory. There’s a probability that none of this lot has actually reached patients at this point in time.

“A hospital reported this very quickly and we worked with Sandoz to make sure it didn’t go further back into production – in other words, into the individual vials.”

Cushman said the quarantine was warranted “in order to protect the safety of Canadians.

“It probably did not affect patient care and, if it did, only minimally.” In Montreal, no hospitals appear to be stocking the mis- labelled morphine ampoules.

At the Mcgill University Health Centre, none of the phar macy departments carry any 2mg/ml ampoules – which are part of the quarantine.

Still, phar macists are checking all their stocks as a precaution.

At the Centre hospitalier de l’université de Montréal, none of morphine given to patients belongs to the affected lots announced by Health Canada, said CHUM spokesperson Lucie Dufresne.

At a hastily called news conference Wednesday night, B.C. Health Minister Mike de Jong called the latest mishap a “troubling complication.” He said local health authorities pre-emptively directed their hospital pharmacists to quarantine all 2mg ampoules of morphine “until Health Canada verifies that the right medication was in the right boxes.”

Isoproterenol hydrochloride is a stimulant that mimics the action of adrenalin, and is used in cases of cardiac arrest until emergency defibrillation or pacemaker therapy can be deployed.

Inadvertent use of the drug instead of morphine “can result in serious health effects,” Health Canada said Wednesday in its urgent advisory to hospitals.

Sandoz has been in the news frequently in recent weeks.

A drug crisis – expected to last at least a year – was triggered last month when Sandoz announced it would cancel production of some drugs and slow production of others following an order by the U.S. Food and Drug Administration to improve quality-control procedures at the company’s plant in Boucherville.

Sandoz is the sole supplier to Canadian hospitals of 90 per cent of all injectable drugs.