Johnson & Johnson (JNJ.N) said on Friday the U.S. Justice Department is investigating the company's marketing practices related to the hip-replacement product it recalled in 2010 over safety concerns.
The diversified healthcare company has also had to recall over-the-counter drugs, contact lenses, heart devices, such as stents, and insulin pump cartridges over the past couple of years.
In August 2010, J&J recalled two types of its ASR metal-on-metal hip implants after they were linked to high failure rates.
Some 93,000 of the ASR hips were sold prior to the recall, which has generated more than 10,000 lawsuits alleging harm from the devices.
J&J said in a regulatory filing that the government is investigating false claims or false statements affecting federal health care programs in connection with the marketing and use of the ASR XL Hip device.
The company said some of its divisions received an informal request in August 2012 from the U.S. attorney's office in Massachusetts and the Justice Department's civil division seeking materials related to the product, the ASR XL Hip device.
J&J said it has voluntarily produced documents in response to the government's informal requests and is fully cooperating with the government's civil investigation.
(Reporting by Neha Alawadhi in Bangalore; Editing by Jackie Frank)