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/.

Watson Recalls Propafenone HCL Tablets Due to Oversized Tablets

Recent increases in recalls due to quality issues have highlighted a need for Quality Assurance (QA) and Quality Control (QC) post packaging within the supply chain especially given the high concentration of contract production/packaging done overseas. One such recall is listed below:

This week Watson Pharmaceuticals, a leading specialty pharmaceutical recalled one lot of Propafenone HCL 225 mg tables in 100 count bottles. This lot number 1112680A with an expiration date of July 31, 2010 is being recalled due to slightly higher levels of the active ingredient.

Propafenone is a medication used to treat cardiac arrhythmias (irregular heartbeats). Some patients who are sensitive may experience potentially serious side effects, including irregular heartbeats or low blood sugar.

More information on this recall is available at: www.watson.com.