BOSTON – Akorn Operating Company LLC, an Illinois-based pharmaceutical company, has agreed to pay $7.9 million to resolve allegations that it caused Medicare to pay false claims.
Specifically, Akorn caused Medicare Part D to pay for three Akorn generic drugs that were no longer eligible for Medicare coverage. As part of the settlement, Akorn admits that it continued to sell generic drugs under obsolete prescription-only labeling.
According to the U.S. Attorney’s Office, FDA-approved “prescription only” (Rx-only) drugs may be dispensed only pursuant to a prescription. Medicare Part D reimburses for Rx-only drugs, but it does not reimburse for “over the counter” (OTC) drugs, which may be purchased by retail customers without a prescription.
The allegations resolved by the settlement agreement were, in part, originally brought in a case filed under the whistleblower, or qui tam, provision of the False Claims Act. The case is captioned U.S. ex rel. Albermarle, LLC v. Akorn Operating Company LLC (D. Mass. 2021). The whistleblower will receive approximately $946,000 from the recovery.
Under the guidelines for taking disclosure, cooperation and remediation into account in False Claims Act cases, the Department of Justice credited Akorn’s cooperation in this matter.
United States Attorney Rachael S. Rollins and FBI SAC Bonavolonta made the announcement. Assistant U.S. Attorney Abraham R. George, Chief of Rollins’ Affirmative Civil Enforcement Unit, and Senior Trial Counsel Augustine Ripa of the Department of Justice handled the matter.
Akorn Operating Company LLC, a pharmaceutical manufacturer which sold, among other products, the following generic drugs: (1) Diclofenac Sodium 1%, a generic nonsteroidal anti-inflammatory cream; (2) Olopatadine Hydrochloride 0.1% and 0.2%, a generic antihistamine eyedrop; and (3), Azelastine Hydrochloride 0.15%, a generic antihistamine nasal spray.
Akorn is required to pay $7.9 million to resolve allegations of causing Medicare to pay false claims. The settlement includes $7.9 million in damages.
The allegations resolved by the settlement agreement were, in part, originally brought in a case filed under the whistleblower, or qui tam, provision of the False Claims Act.
Akorn Operating Company LLC, an Illinois-based pharmaceutical company, has agreed to pay $7.9 million to resolve allegations that it caused Medicare to pay false claims.
According to the U.S. Attorney’s Office, the settlement agreement requires Akorn to admit that it caused Medicare Part D to pay for three Akorn generic drugs that were no longer eligible for Medicare coverage.
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Key Facts
- State: Massachusetts
- Category: Drug Trafficking|Fraud & Financial Crimes|White Collar Crime
- Source: DOJ Press Release â†â€â€
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