K-V Pharmaceutical says it will not resume shipping products until at least the 4th quarter

K-V Pharma won’t resume shipping until 4Q or later

ST. LOUIS — K-V Pharmaceutical Co., which hasn’t shipped any products in more than a year, said Friday it won’t be able to resume sales until October at the soonest and may have to make new cuts to its operations.

K-V stopped all manufacturing and shipping in January 2009 after a series of product recalls. The company said Thursday it does not expect to resume shipments until the fourth quarter of 2010 at the earliest. K-V is in the process of closing its Ethex generic drug unit, but said it may have to reduce operations even more to stay in business.

K-V said it is working with the Food and Drug Administration to get its products back on the market, but its top priority is maintaining and trying to increase its cash and financial resources.

The news sent its shares tumbling 55 cents, or 20 percent, to $2.26. Earlier, they fell as much as 28.5 percent.

Last month, K-V pleaded guilty to charges it failed to inform regulators about manufacturing problems that caused some of its pills to be too large, which could have lead to accidental overdoses. It agreed to pay $27.6 million to settle government investigations into its business.

The FDA told the company to stop making some time-release drugs in 2008, but K-V did not comply, which led to millions of dollars worth of products being seized by the agency.

In late 2008 and early 2009, the company issued several recalls because of the oversized pills, and in January 2009 it shut down all manufacturing. Most of the recalled products were made by the Ethex unit, but some were made by its Ther-Rx specialty drug division.

The company also said it completed its quarterly reports through March 31, 2009, which was the end of its most recent fiscal year. K-V is working on its quarterly reports for the June, September, and December quarters.