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/.

FDA MedWatch: Barr Laboratories Recall On Potentially Super-Potent Tablets

Barr Laboratories, Inc. issued a voluntary recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) 20mg Tablets, 100 count bottles, lot number 311756. The product is being recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets.

Clinically significant adverse reactions to a supra-therapeutic dose could include cardiovascular, neurologic, psychiatric and gastrointestinal reactions. Customers who have this lot in their possession are instructed to cease using the product and return it to their pharmacy/distributor.

XStream Systems, endorses material screening of medications within the supply chain from manufacturer to dispenser to significantly reduce issues with product quality, adulterated and counterfeit medications. By using solutions like XStream’s XT250, a user can verify and authenticate medications inside their sealed, unit-of-sale container without opening or destroying the product.

Read the MedWatch safety summary, including a link to the firm's Press Release, at:
www.fda.gov.

XStream Systems Stories and News for the Week of October 24, 2008

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the ever growing issues of counterfeit and adulterated medications. XStream Systems thinks that its revolutionary technology that is capable of materials analysis of medications inside of sealed containers will be an important part of solving this global problem:

Demand for Foreign Products Changing FDA, Official Says
The FDA needs to shift its approach on imports to one that minimizes risk at each point in the product life cycle — from foreign manufacture to domestic use, according to Timothy Ulatowski, director of compliance in the agency’s Center for Devices and Radiological Health. The FDA will release a draft guidance soon that outlines standards for third-party certification programs for FDA-regulated products, he said. It also is preparing a draft guidance on good importer practices.

A New "Double-Dose" Pill Drug Recall Is Issued By ETHEX Corp.
ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient.

FDA To Open Multiple Inspection Offices Abroad By Year-End
The U.S. Department of Health and Human Services will send the first FDA inspection teams to new offices in China, India, Europe, and Latin America before the end of 2008, according to HHS. "In the past year, we've upgraded labs and equipment, hired additional staff, and begun implementing product safety agreements with key trading partner, including China," stated HHS Secretary Mike Leavitt.

FTC Breaks Up Spam Network Which Illegally Sold Drugs Online
The Federal Trade Commission said Tuesday that it has broken up a global spam network responsible for sending billions of illegal messages encouraging consumers to buy unsafe male-enhancement and weight loss pills. The spam network, which processed credit card information in Cyprus and Georgia, used servers in China to host its websites. The FTC said the network used by this operation compromised tens of thousands of computers around the world and was capable of sending up to 10 billion spam messages per day. The bogus drugs were shipped from China and India.