Unapproved Dental Drug Goes Up in Smoke
January 3, 2008 by

Root canal filler containing a toxic substance was destroyed under court order at FDA’s request because it was an unapproved drug whose safety and effectiveness had never been established. An environmental services company burned the product in an incinerator. Harvey Altholtz, D.M.D., president of the Connecticut firm that distributed the filler, had asserted that because …

Unapproved ‘Brain Wave’ Devices Condemned after Seizure Reports
February 13, 2005 by

Under an FDA-requested court order, 78 seized cartons of unapproved medical devices valued at $200,000 were destroyed in Little Rock, Ark., in June 1993 after at least 12 complaints attributed epileptic seizures to their use. The manufacturer destroyed another $200,000 worth of the devices rather than have them seized. The devices were various models of …

Magnetic Devices Seized
June 1, 1993 by

At FDA’s request, the U.S. Marshals Service recently seized and destroyed magnetic devices valued at some $42,000 because the products were being marketed illegally with unsubstantiated medical claims. The device, known as Elekiban, was a quarter-inch magnetic disk attached to a circular adhesive patch. According to the labeling, users should place the Elekiban patch on …