In connection with a 2012 outbreak of meningitis that killed 64 people across nine states, two owners and 12 former employees of a US pharmacy were arrested Wednesday, prosecutors said.
Barry Cadden and Gregory Conigliaro owned the New England Compounding Center (NECC), which lost its license in 2012 after inspectors found it guilty of multiple sanitary violations.
The pharmacy, located in the city of Framingham, Massachusetts in the US northeast, voluntarily shut down and recalled all products following the unprecedented outbreak of fungal meningitis.
The US Centers for Disease Control and Prevention said the outbreak was caused by contaminated vials of preservative-free methylprednisolone acetate manufactured by NECC.
The CDC said 751 patients in 20 states were diagnosed with a fungal infection, of whom 64 patients in nine states died.
A detailed, 73-page grand jury indictment unsealed in Boston leveled 131 charges against the defendants, including racketeering, mail fraud, conspiracy and second degree murder.
The most serious charges were leveled against Cadden and supervisory pharmacist Glenn Chin, who face up to life in prison if convicted on all counts.
They were charged with 25 acts of second degree murder for allegedly causing the deaths of eight people in Michigan, seven in Tennessee, three each in Indiana and Maryland, two in Virginia and one each in Florida and North Carolina.
The indictment alleges that from 2008 to 2012, the pharmacy used expired ingredients to make drugs, falsely labelled drugs, failed to properly sterilize drugs, failed to properly clean and disinfect working areas and shipped out untested medications.
It accuses the pharmacy of delivering untested drugs and drugs made with expired ingredients across the country.
It also alleges drugs were made by an unlicensed technician and names of celebrities were used to create fraudulent prescriptions, such for a Michael Jackson and a Diana Ross in Nebraska.
"The Department of Justice is taking decisive action to hold these individuals accountable for their alleged participation in grievous wrongdoing," said Attorney General Eric Holder.
"Actions like the ones alleged in this case display not only a reckless disregard for health and safety regulations, but also an extreme and appalling indifference to human life."
"American consumers have a right to know that their medications are safe to use," he added.
The outbreak led to calls for tighter regulation of the loosely controlled US pharmaceutical compounding industry.
The fungus that contaminated the steroids was so prevalent it could be seen with the naked eye in some vials.
Critics said drug manufacturers found a way to sidestep costly and strict oversight by classifying themselves as pharmacies, which are given freer rein to mix drug compounds for patients.