Johnson & Johnson disclosed Wednesday that the health products giant has now received multiple subpoenas from federal prosecutors related to repeated recalls of Tylenol and other consumer health products.
The grand jury subpoenas request “documents broadly relating to” both the recent recalls of products made by McNeil Consumer Healthcare and inspections of two of the unit’s factories.
One of the plants, in the Philadelphia suburb of Fort Washington, Pa., has been shut down since April due to multiple problems. The other, in Lancaster, Pa., wasn’t following rules for manufacturing quality and record-keeping. Food and Drug Administration inspectors noted many severe problems after spending a dozen days there.
Johnson & Johnson disclosed the grand jury subpoenas, filed by the U.S. Attorney’s Office in Philadelphia, in its quarterly financial filing with the Securities and Exchange Commission.
The maker of Band-Aids, birth control and biotech drugs said it is cooperating with the U.S. Attorney’s Office in responding to the subpoenas.
“The company and its subsidiaries are vigorously contesting the allegations asserted against them and otherwise pursuing defenses to maximize the prospect of success,” J&J said in the quarterly filing.
Company officials declined further comment.
New Brunswick, N.J.-based J&J has been under scrutiny by Congress, FDA officials and others for eight recalls since September covering tens of millions of bottles of pain reliever Tylenol and other popular nonprescription medicines. That includes some liquid medicines for children.