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.

FDA Instructs Pharma Companies to Watch for Melamine

Pharmaceutical-Technology.com reported in its August 7, 2009 on-line edition on FDA guidance and instructions on protection to the pharmaceutical supply chain, specifically as it relates to Melamine. Melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilizers and pesticides.

Here are some highlights from the article:

• The US Food and Drug Administration (FDA) warned drug companies to scrutinize certain pharmaceutical ingredients for the presence of melamine and has issued industry guidance on how to protect against contamination.


• The FDA has stressed that there is no evidence that melamine, which if ingested in significant amounts can lead to kidney failure or death, has entered the pharmaceutical chain but that recent contaminations in pet food and in infant milk in China have proven the need to be vigilant.


• The FDA has released guidance as an initial measure with pharmaceutical manufacturers, re-packers, other suppliers and pharmacists to conduct melamine testing.


• The FDA identified specific pharmaceutical ingredients recommended for screening, and has also recommended specific FDA-published methods for this testing.


• "The FDA urges the implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain," Hamburg said.

XStream’s authentication and verification technology tests the product inside its sealed, unit-of-sale container and can protect the pharmaceutical supply chain by screening inventories at the point of production, distribution and dispense without destroying the medication or disrupting the container by opening.

To learn more about XStream Systems, visit us at www.xstreamsystems.net.

To read the article in full, follow the link below:
http://www.pharmaceutical-technology.com/news/news61460.html?WT.mc_id=DN_News

Drug Companies Need to Improve Their Screening for Quality and Counterfeits

By: Alan Clock, Senior Vice President, XStream Systems, Inc.

Recent massive recalls on generic drugs imported from overseas contract manufacturers are making significant reverberations within the pharmaceutical industry and making the case for more stringent screening of drugs both in finished form and in raw materials.

Manufacturers in the past have seemingly been immune to this level of public scrutiny because it has often been perceived that their products are at their most pristine at the point of manufacture however with the continued proliferation of contract manufacture of product and raw material sourcing from companies located in lesser developed countries the need for more robust screening from point of manufacture through the supply chain seems obvious.

These global recalls are not just happening to the smaller generic companies that contract their manufacturing overseas but also the generic divisions of big Pharma companies are feeling the sting of substandard product within their brand.

Although the liability to the stakeholders of these impacted companies is great, the impact and consequence to the consumers of these inferior medications should remain paramount. For those in the know within the pharmaceutical supply chain, the message and actions seem clear.

XStream Systems supports the concept of screening products throughout the pharmaceutical supply chain from raw materials, to the point of manufacture, packaging, throughout the supply chain and finally at the point of dispensing to the patient.

The level of screening required is important as well, realize that all of the poor quality recently recalled product in question were passed or would have been passed on to the consumer through the process of pedigree, serialization, bar codes and RFID tags.

End-to-end screening does not have to be costly, overly time consuming or onerous to the various members of the supply chain. Current technologies exist to rapidly screen raw materials at the point of production while XStream’s XT250 has a robust solution of analytical testing of products within the sealed container in the supply chain. At the point of dispense there are a variety of technologies available currently which test for product quality and medication errors before they reach the consumer. We at XStream believe that the most effective way of protecting the product is to employ a variety of solutions at each link of the supply chain.

As the world continues to move to a global economy and the pieces of the pharmaceutical supply chain scatter beyond borders a watchful eye towards quality and security are in the interest to all of those who either make a business of or consume pharmaceuticals.

Ranbaxy; More Concern over Substandard Medications

This year of 2008 should go down in the history books as the year of drug safety concerns. The latest concerns are over FDA accusations that Ranbaxy Laboratories sold substandard drugs and knowingly concealed the facts.

Ranbaxy is one of India’s largest generic manufacturers and 25% of their sales are in the U.S. They have been accused of using raw materials from unapproved sources in one of their northern India plants and altering in-house testing to meet FDA standards which resulted in sub-potent, super-potent or adulterated products.

"The government has reason to believe that these violations have resulted and continue to result in the introduction of adulterated and misbranded products" into the US market, federal prosecutors said.

This coupled with earlier cases this year of adulterated heparin from China, has left consumers doubting the safety of their medications. Most troubling is that the current methods being considered would not be effective in verifying the validity or purity of the drug itself.

Incidents such as this illustrate the need for an authentication of the product as a way to protect all of the members of the Pharmaceutical Supply Chain and most importantly the consumer. Track and Trace technologies (pedigrees and RFID) will not protect the consumer from these types of incidents which we can expect to happen more frequently as we continue to increase our reliance on global sources for our medications. Only XStream Systems’ XT250 has the solution to authenticating the product inside the sealed container. This is the only solution to this clear and present danger.