(Reuters) - A unit of AmerisourceBergen Corp, one of the largest U.S. drug wholesalers, has agreed to pay $625 million to resolve a U.S. government probe involving pre-filled syringes, the company said in a filing with U.S. securities regulators on Tuesday.
The agreement, whose final terms are still being negotiated and which must be approved by a court, comes on top of a $260 million criminal penalty that the subsidiary, AmerisourceBergen Specialty Group, agreed to pay in September as part of a criminal guilty plea.
The company previously disclosed a $575 million reserve for a possible civil settlement in the case.
Keri Mattox, a spokeswoman for AmerisourceBergen, declined to comment beyond Tuesday’s public filing with the U.S. Securities and Exchange Commission.
The federal probe involved the pre-filled syringe program of AmerisourceBergen Specialty Group’s now-defunct Medical Initiatives Inc subsidiary, as well as certain oncology products, according to the company’s filing.
In a court document filed in September, AmerisourceBergen admitted that Medical Initiatives packaged syringes of cancer drugs at an Alabama facility that was not registered with the U.S. Food and Drug Administration, as required by federal law, pleading guilty to a misdemeanor charge.
The company also admitted in the September filing that Medical Initiatives illegally dispensed syringes based on order forms that were not prescriptions signed by medical practitioners. It added that it submitted syringes on behalf of single patients in excess of safe doses.
AmerisourceBergen said the violations occurred from 2005 until 2014.
In a criminal information unsealed in September, U.S. prosecutors also charged that Medical Initiatives prepared syringes by pooling drugs sold in glass vials that were meant for a single use, and did not maintain a sterile environment in its facility, resulting in contamination in some syringes.
AmerisourceBergen did not plead guilty to those charges or admit any wrongdoing related to them.
Reporting by Brendan Pierson in New York; Editing by Cynthia Osterman and Peter Cooney