Over the past year the Ethex Corporation has recalled several of its drugs due to a manufacturing defect causing the pills to be oversized. This can cause serious side effects, overdose, or death. If you or a loved one have been injured by one of the Ethex Recall Drugs side effects you may be entitled to compensation. Contact the Ethex lawyer about an Ethex lawsuit today. Call our Ethex lawyers toll free at: 1-800-856-6405 or fill out our free Ethex case evaluation form on this page.

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KV Pharmaceutical Agrees to Improve Drug-Making

-Bloomberg

03/04/2009- KV Pharmaceutical Co., a St. Louis drugmaker, agreed to improve its manufacturing processes to resolve a U.S. Food and Drug Administration lawsuit filed in the wake of a shutdown of the company’s production.

“We have been working diligently with the FDA for the last two months to reach agreement on a clear path forward,” KV interim Chief Executive Officer David Van Vliet said today in a statement released in conjunction with the FDA’s filing of a St. Louis federal court complaint accusing the company of poor quality control and mislabeling.

A maker of women’s health products and generic drugs, KV in January announced it was suspending the manufacturing and shipping of all products and recalling most of them, saying then it was acting in accord with the FDA, which had inspected its facilities in December.

KV has lost 62 percent of its value this year. Its stock rose 42 cents, or 62 percent, to $1.10 in New York Stock Exchange composite trading.

U.S. Marshals and FDA agents in July seized more than $24 million in medications not yet approved for use in the U.S. at the company’s Bridgeton, Missouri, facilities, said St. Louis U.S. Attorney Catherine Hanaway at the time.

In a consent decree filed with the FDA complaint today, KV and two units promised they will destroy all finished drug products in its possession within 45 days, as well as those that were recalled from May to February.

Independent Expert

The company and its managers also agreed to pay an independent expert to act as a manufacturing-practices expert to ensure its processes for drug-making, labeling and shipping meet industry standards.

That decree still requires court approval.

“The FDA will carefully monitor the provisions of this injunction,” Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs, said in a statement. KV can’t resume manufacturing and sales until the independent compliance officer and the agency give their approval, according the FDA statement.

The case is U.S. v. KV Pharmaceutical Co., 09cv334, U.S. District Court, Eastern District of Missouri ( St. Louis).

If you or a loved one have been injured by Ethex Morphine or Ethex Propafenone you may be entitled to compensation. Contact the attorneys of Ennis & Ennis, P.A. today for a free case evaluation by filling out the form on this page or calling the toll free number listed below. Our staff is standing by to answer any questions you may have about the Ethex Morphine Recall, Ethex Propafenone Recall, and potential Ethex Corporation lawsuits.

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