Noblesville pharmacy recalls 'super-potent' drug after it sickened 3 newborns

A Noblesville compounding pharmacy company has issued a recall for an intravenous form of a narcotic painkiller, saying that it was too powerful to be safe for use.

But the recall from Pharmakon Pharmaceuticals did not come in time to help three infants who suffered “serious adverse events,” according to the Food and Drug Administration. The painkiller — morphine sulfate, which is an opioid — can lead to breathing problems, coma or even death if injected in too high a dose.

Pharmakon, a compounding pharmacy licensed in about 20 states, distributed a “super-potent” form of the drug to a medical facility in Indiana and one in Illinois.

The company produced the narcotic on Feb. 3 and issued a voluntary recall eight days later after lab results showed that it was too powerful. On Feb. 16, the FDA learned about the three babies who had the adverse reactions.

Pharmakon officials declined to comment on the incident.

“Because there is an ongoing review of the matter and discussions with the FDA, we are not in a position to comment on it now,” said Elizabeth Prokopik, Pharamakon’s attorney.

This is not the first time that Pharmakon, which recently relocated from Carmel to Noblesville, has had problems.

In the spring of 2014, the company voluntarily recalled multiple lots of a sedative that was almost twice as strong as what the label said. In that same time period, the FDA conducted an inspection of the Pharmakon facility after receiving reports of newborns who had reactions after they were given an incorrectly labeled sedative.

The agency sent the company a warning letter in 2015 detailing a number of concerns, including what it termed “serious deficiencies” in sterile practices. These included touching nonsterile surfaces with gloved hands and continuing to work without disinfecting those gloves.

Inspections conducted in 2014 also found that the company produced a drug that was not as strong as it should have been and produced medications intended for use by laymen that did not contain adequate directions.

The 2015 letter from the FDA acknowledged that the company had taken action to correct some of the problems but said that more work needed to be done.

“The FDA strongly recommends that your management immediately undertake a comprehensive assessment of your operations,” the letter said.

Compounding pharmacies, in general, have come under increased scrutiny in recent years, after a 2012 meningitis outbreak was traced to contaminated products sold by a New England company. That outbreak killed more than 60 people and sickened more than 600.

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Call IndyStar reporter Shari Rudavsky at (317) 444-6354. Follow her on Twitter: @srudavsky.