ST. LOUIS, Jan. 26 /PRNewswire-FirstCall/ -- KV Pharmaceutical (NYSE: KVa/KVb) has voluntarily suspended the manufacturing and shipping of all of its products, other than certain products that it distributes but does not manufacture. The suspension began on January 22, 2009.
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 U.S. Food and Drug Administration (FDA).
These actions are being taken in cooperation with the previously announced inspection by the FDA of the company's operations and inventory, which began in December. To resume shipments as quickly as possible, the company is working with a third-party consulting group, Lachman Consultant Services, Inc., to review manufacturing and packaging processes.
"The new leadership team at KV realizes that we are in a very challenging time for the company," said interim President and CEO David Van Vliet. "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."
KV expects these actions to have a material adverse effect on its financial condition, and as a result, may not be in compliance with one or more covenants included in a credit agreement with its lenders. As of December 31, 2008, the outstanding balance under this line of credit was approximately $30 million.
The company's Board of Directors has appointed a special committee
consisting of the following members of the Board: Jean M. Bellin, Kevin S.
Carlie, Terry B. Hatfield, Jonathon E. Killmer and Norman D. 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 cla
|SOURCE KV Pharmaceutical Company|
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