Pill Mix Leads to Cancer Drug Recall

Cross contamination has led to the recall of a cancer drug shipped to the U.S.

According to a report written by George Miller in FiercePharma, the recalled drug is Fresenius Kabi's anastrozole, and it was made by the German company's subsidiary in India, Fresenius Kabi Oncology.

The voluntary recall involves two batches of the tablets, which are used to treat breast cancer. They were made available in the U.S. by APP Pharmaceuticals, Kabi's U.S. unit based in Schaumburg, Illinois.

The drug was made at the Indian unit's plant in Baddi. Operators found drugs other than anastrozole in some of the 1-mg anastrozole bottles, according to the Economic Times. The recall comprises 7,192 bottles, each containing 30 tablets.

The specifics of the FDA recall are:

PRODUCT
Anastrozole tablets, 1 mg, 30 Tablets per HDPE Bottle, Rx only; NDC #63323-129-30; Product Code: 129030. Recall # D-906-2010

CODE
Lot numbers 870AF0010, Exp. date: 05/2012; Lot number: 870AF00201; Exp. date: 05/2012

RECALLING FIRM/MANUFACTURER
Recalling Firm: APP Pharmaceuticals LLC, Schaumburg, IL, by letters dated September 1, 2010. Manufacturer: Fresensius Kabi Oncology Limited (Baddi), Baddi, India. Firm initiated recall is ongoing.

REASON
Cross Contamination w/Other Products: A potential for some foreign tablets to be in bottles of anastrozole tablets 1 mg.

VOLUME OF PRODUCT IN COMMERCE
7,192 bottles

DISTRIBUTION
Nationwide

As more and more pharmaceutical products are outsourced from underdeveloped countries and nation's with a checkered history of regulatory control, it is important that all members of the pharmaceutical supply chain, especially the contracting entity, utilize authentication technologies to make certain of the quality of the products that make up their brand.

To read the FiercePharma post, visit: http://www.fiercepharmamanufacturing.com/story/pill-mix-leads-cancer-drug-recall/2010-10-13#ixzz12RCjXsX9

To learn more about pharmaceutical authentication technologies, visit: http://www.xstreamesystems.net/.

Drug Cargo Theft: The New Goldmine

Top 10 Pharma Cargo Thefts By Value

Eric Duggan in the June 29th edition of the FiercePharma Manufacturing, writes an excellent story encapsulating the proliferation of pharmaceutical cargo theft and how it has become one of the most profitable and dangerous crimes to the public-at-large in the 21st century.

The story, aptly titled Drug Cargo Theft: The New Goldmine, describes how this specific criminal activity is likely to continue to grow because of the huge profits gleaned from targeting pharmaceuticals.

Mr. Duggan presents the listing of the top 10 ten pharmaceutical thefts in the 2009 and 2010 to-date, which with few exceptions, seem to have been lightly reported about in the media or otherwise not well known by the general public.

The reality is that with relative ease, a criminal can target a pharmaceutical shipment or warehouse and potentially make millions on the sale of the stolen product along with the ability to gain significantly more by other illegal activities after the fact.

The following is a list of the Top Ten Pharmaceutical Thefts of 2009 and 2010 (to date):

• Eli Lilly Warehouse - $76M
• Eli Lilly Truck - $37M
• Teva Truck - $11.8M
• Novo Nordisk Truck - $11
• Astellas Truck - $10M
• Unknown company - $8.8M
• GSK Warehouse - $5M
• Exel Distribution Center - $3M
• Dey Pharmaceuticals Truck - $2M
• Dey Pharmaceuticals Truck - $2M

With hundreds of millions of dollars of pharmaceuticals cycling through a black market the criminals have the ability to double their profits of the theft by separating the product from the packaging, selling the product and then put counterfeit product into the packaging and sell that as well.

With the advent of the internet, there is also a ready made, anonymous tool to market their stolen and fraudulent goods directly into consumers and the legitimate supply channel for even higher margins.

In a sense pharmaceutical cargo theft and its down stream activity seemingly is a perfect crime. It has high profitability, there is the ability to double dip on the spoils of their theft by adding counterfeit product to packaging and they can sell their stolen wares into legitimate supply chains globally through the anonymity of the internet.

Here are some of the highlights of Mr. Duggan’s FiercePharma story:

• Stolen drugs are most often shipped to Latin America or to illegal online pharmacies. Sometimes they also make their way back into the legitimate supply chain with new fake labels. This poses a potent public health risk that keeps the FDA involved, issuing recalls and investigating cases through its Office of Criminal Investigations.

• Aside from the appealing pay-off, cargo theft has gained momentum in the U.S. because of the relatively light penalty thieves risk if caught. As reported in Security Director News, cargo theft in the past has been viewed as a victimless crime, leading to slow response from law enforcement. According to Keith Lewis, task force agent for the major theft unit of the Georgia Bureau of Investigation, "This is a very easy crime to commit and get away with. Law enforcement does not understand the nature of this crime." courtesy of FreightWatch International.

Fortunately Mr. Duggan offers some hope that there are some efforts being made to combat this crime:

• Greater industry efforts to combat the crime are already having an effect, however. The Transported Asset Protection Association (TAPA) offers a snapshot of cargo-theft in its 2009 incident information report, noting, "With an insight into the industry, the data signify the beginnings of a trend toward improvement--and a greater adherence to supply chain security practices throughout the pharmaceutical supply chain."

• Cooperation is improving between industry and law-enforcement. Companies like FreightWatch and the newly minted CargoNet offer loss control services, including compiling crime data and coordinating with law enforcement. CargoNet managing director Maurizio Scrofani told us, "There is a problem in fragmentation [of data]. You need a central database to tie in regional databases, which is a common way of pulling in law enforcement."

The era of pharmaceuticals targeted for criminal activity carries a huge price tag to the downstream consumer with the potentially deadly effects of contamination, adulteration and counterfeiting impacting the health of large groups of a population.

Secure Pharma Chain Blog encourages all members of the supply chain to deploy technologies and solutions to both secure and authenticate their inventories from the criminal acts of theft, fraud, adulteration and counterfeiting.

Read more of the FiecePharma article, visit: ttp://www.fiercepharmamanufacturing.com/special-reports/top-10-pharma-cargo-thefts-value-2009-2010?utm_medium=nl&utm_source=internal#ixzz0sR3PFWnN

To learn more about pharmaceutical supply chain technologies, visit: http://www.xstreamsystems.net/.