Showing posts with label KV Pharmaceuticals. Show all posts
Showing posts with label KV Pharmaceuticals. Show all posts

Wednesday, March 31, 2010

K-V Pharmaceutical May Not Resume Sales Until 4th Quarter

K-V Pharmaceuticals announced last week that it will not resume sales until October 2010 at the earliest and may have to cut operations to stay in business.

K-V stopped all manufacturing and shipping in January 2009 after a series of product recalls and has closed its generic drug unit Ethex.

K-V pleaded guilty in February 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.

The K-V saga is a cautionary tale of a company who has suffered from a lack of product quality control, testing and verification. Had authentication technologies been in place at the point of manufacture, distribution or dispense the issue of manufacturing difficulties would have been discovered prior to the dispensing of the drug to any consumer.

XStream Systems encourages the entire pharmaceutical supply chain to employ authentication and verification technologies from end to end to protect inventories and consumers.

Friday, February 26, 2010

KV to Shut Down Ethex


According to published reports from Bloomberg News, the Associated Press and the St. Louis Post Dispatch, KV Pharmaceuticals has reached an agreement with the U.S. Department of Justice regarding an investigation into Ethex Corp, its generic pharmaceutical marketing and distribution subsidiary.

KV Pharmaceutical must pay $27.6 million in fines and an administrative forfeiture to cover costs of the investigation. Additionally KV plans on ceasing operation of its Ethex generic drug business.

This agreement comes after Ethex plead guilty to criminal charges for not disclosing issues with two to its drugs.

The agreement with the U.S. Attorney and the Department of Justice is subject to court approval and revolves around the 2008 investigation into Ethex which halted production and recalled drugs after making oversized tablets.

Specifically Ethex plans to plead guilty to two felony counts of failure in 2008 to file field alerts for the generic drugs Dextroamphetamine and Propafenone.

These incidents of substandard medications were significant and could have adversely affected the health of many consumers. Had material screening been in place within the supply chain, these substandard materials would have been intercepted prior to them reaching a dispenser and ultimately the consumer.

To learn more about material screening solutions within the pharmaceutical supply chain, visit: http://www.xstreamsystems.net/.