KV Pharmaceutical Recalls Tablet-Form Drugs
KV Pharmaceutical (NYSE: KV-A) has advised the U.S. Food and Drug Administration (FDA) that, effective midnight Dec. 19, 2008, the company voluntarily suspended all shipments of all FDA approved drug products in tablet form.
This action is being taken as a precautionary measure to allow KV to expeditiously review and enhance comprehensively the company's manufacturing and quality systems, and to implement efficiency improvements in its production facilities. KV is keeping the FDA informed about the company's plans.
KV Pharmaceutical is also recalling a single production lot of Hydromorphone HCl 2 mg tablets (Lot 90219, Exp: 3/2010; NDC 58177-0620-04), a pain management drug, following the report of an oversized tablet. Additional details on this recall were provided in an ETHEX Corporation press release also issued today and will be posted on kvpharmaceutical.com .
"We are convinced that holding product shipments is the fastest track to enhancing quality systems. The traditional approach of a methodical, slower track was an option, but Terry Hatfield, the new chairman of the KV Pharmaceutical board of directors, and I believe that the short-term, financial investment will better improve the quality reputation all stakeholders value," David Van Vliet, newly appointed KV Pharmaceutical Interim CEO, said.
"I want to reassure patients, physicians, pharmacists, and care-givers that we are committed to providing them with safe and effective products," said Van Vliet, who was named to the Interim CEO position on Dec. 5. "The company's new leadership team is taking immediate action to identify all practices and processes that can be enhanced to improve the efficiency and consistency of the company's manufacturing."
"We will continue to work closely with the FDA as we move forward, giving these matters our highest priority," Van Vliet said. "We have retained Lachman Consultants, a team of highly experienced experts from industry and government, to help us identify opportunities in the design and implementation of processes that assure sustainable compliance."
At this time, the company is unable to determine when distribution of tablet-form products will resume, or estimate what the financial impact of the recall and suspension will be. While the specific financial impact of these events cannot be presently estimated, management believes that the Company's operating results are likely to be materially adversely affected. The company generated net revenues in fiscal 2008 of $159 million from the products that are the subject of the current product shipment hold. The timing of re-starting shipments of the affected products will depend on the time required to implement the modifications guided by KV's new leadership team and overseen by Lachman Consultants, keeping the FDA informed about actions taken. At this time, we do not anticipate that all of the manufacturing and quality assurance issues will be resolved by the end of the current fiscal year.
"KV's leadership team is fully engaged and committed to this effort. These changes are an investment in the future success and growth of the company. While this will be a near-term hardship for KV, with reduced revenues and higher costs, we are committed to acting decisively and to making necessary enhancements across our operations. By taking these bold actions, we will emerge far stronger as a company," Van Vliet said.