Two owners and 12 former employees of a US pharmacy have been arrested in connection with a 2012 outbreak of meningitis that killed 64 people across the country, prosecutors said.
Barry Cadden and Gregory Conigliaro owned the New England Compounding Centre (NECC), which lost its licence in 2012 after inspectors found it guilty of multiple sanitary violations.
The pharmacy, 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 Centres for Disease Control and Prevention says the outbreak was caused by contaminated vials of preservative-free methylprednisolone acetate manufactured by NECC.
The CDC says 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 levelled 131 charges against the defendants, including racketeering, mail fraud, conspiracy and second degree murder.
The most serious charges were levelled against Cadden and supervisory pharmacist Glenn Chin, who face up to life in prison if convicted on all counts.
They were charged on Wednesday with 25 acts of second degree murder.
The indictment alleges that from 2008 to 2012, the pharmacy used expired ingredients to make drugs, falsely labelled drugs, failed to properly sterilise drugs, failed to properly clean and disinfect working areas and shipped out untested medications.
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.
The fungus that contaminated the steroids was so prevalent it could be seen with the naked eye in some vials.
Critics say drug manufacturers have 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.
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