The ETHEX / KV Pharma Recall: One Year Later

February 16, 2010, 7:45AM. By Gordon Gibb

St. Louis. MOIt has been a little over a year since ETHEX Corporation, a wholly owned subsidiary of KV Pharmaceutical, also known as KV Pharma, recalled a number of drugs due to the fact that the tablets were oversized, putting patients at risk of accidentally overdosing on prescribed medications.

On February 3, 2009, ETHEX distributed an updated recall letter urging the immediate recall of all lots of generic medications ranging from Dextroamphetamine to morphine and Isisorbide Mononitrate tablets of various strengths, due to the potential for the tablets to be oversized.

A month later KV Pharma was on the defensive, agreeing to improve its manufacturing processes. According to a 3/4/09 report from Bloomberg News, the US Food and Drug Administration (FDA) accused the manufacturer of poor quality control and mislabeling, filing a formal complain in federal court in St. Louis.

The previous July, US Marshals and FDA agents seized more than $24 million in medications not yet approved for use in the US. The company had to agree to destroy all finished drug products in its possession at the time within 45 days of the filing of a consent decree, in addition to those products recalled from May through February of last year.

KV Pharma was instructed not to resume production until the FDA and an independent compliance officer gave it the nod.

Since then, things have been quiet on the KV Pharma front. Aside from links to previous recalls emblazoned in red and readily accessible on the KV Pharma homepage, there is little hint of any prior trouble. It appears to be business as usual—although there was mention made of cGMP compliance in a statement posted on January 11 of this year with regard to the securing of full US and worldwide rights to Gestiva.

"While our highest priority is to demonstrate cGMP compliance so we can return our approved products to market, we believe Gestiva will be an important addition to our women's health franchise and are pleased we could reach this agreement with Hologic," said David Van Vliet, interim CEO at KV Pharmaceutical Company. "We will continue to assist Hologic in completing the steps to obtain FDA approval of this socially valuable product."

It should be noted that Van Vliet was named President and Chief Executive Officer of ETHEX, which is KV Pharma's largest subsidiary, in August 2008. Four months later he was elevated to interim CEO of KV Pharmaceutical Company.

Fourteen months later Mr. Van Vliet continues to serve as President and CEO of the firm, but only on an interim basis.