Additionally, the company will conduct a voluntary recall of most of its products. The scope and depth of the recall are currently under discussion with the FDA. These actions are being taken in co-operation with the previously announced inspection by the FDA of the company’s operations and inventory, which began in December 2008.
To resume shipments as quickly as possible, the company is working with a third-party consulting group, Lachman Consultant Services, to review manufacturing and packaging processes.
The company’s board of directors has appointed a special committee consisting of the following members of the board: Jean Bellin, Kevin Carlie, Terry Hatfield, Jonathon Killmer and Norman Schellenger. Mr Hatfield, the chairman of the board, has been appointed to serve as the chairman of the special committee.
The special committee was formed in response to the initiation of a series of putative class action shareholder lawsuits alleging violations of the federal securities laws by the company and certain individuals as well as the receipt of an informal inquiry from the SEC.
David Van Vliet, interim president and CEO of KV Pharmaceutical, said: The new leadership team at KV realizes that we are in a very challenging time for the company. We are committed, however, to resolving these issues and resuming production as soon as possible by working closely with the FDA and the independent experts from Lachman Consultant Services.