Showing posts with label material screening. Show all posts
Showing posts with label material screening. Show all posts

Wednesday, January 6, 2010

Teva Expands Nationwide Recall of Ketamine

Teva Animal Health Inc. is expanding a nationwide recall of its Ketamine Hydrochloride Injection which effect products under seven manufacturer’s labels because of adverse events including the death of some animal patients. The labels include specific lots of Ketamine products from Fort Dodge Animal Health, Vedco, AmTech Group, Butler, Phoenix Pharmaceuticals, Rx Veterinary Products and Lloyd Laboratories. This enhanced recall energizes the need for material screening of products within the supply chain to protect consumers from fraud, adulteration, contamination and counterfeit products. The following press releases include details on the recall:

Teva Animal Health, Inc. Expands a Voluntary Nationwide Recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials

December 21, 2009 - Teva Animal Health, Inc. is expanding a nationwide voluntary recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials for all lot numbers within their expiration dates to the Veterinary Level. This product had previously been recalled to the distributor level and is being expanded as a result of an increased trend in serious adverse events associated with this product.

Veterinarians who have this product in their possession are instructed to cease using the product immediately and return it to their distributor.

Ketamine Hydrochloride is a rapid acting, non-narcotic, non-barbiturate agent for anesthetic use in cats and for restraint in subhuman primates. This recall is being conducted as a result of an increased trend in serious adverse events associated with this product, including lack of effect, prolonged effect, and death and involves all lot numbers within expiration.

Teva Animal Health, Inc is voluntarily recalling the aforementioned product. The FDA has been apprised of this action.

Consumers with questions may contact 800-759-3664 from 8:00am – 5:00pm CST Monday-Friday. http://www.fda.gov/Safety/Recalls/ucm195118.htm

Seven Labels Tied to Teva Ketamine Recall, FDA says

In the wake of Teva Animal Health’s massive ketamine recall, the U.S. Food and Drug Administration (FDA) reports that the action extends to lot numbers of Fort Dodge Animal Health’s Ketaset, Vedco’s Ketaved and five other private labels.

An e-mail to the VIN News Services (VNS) from the FDA’s Center for Veterinary Medicine (CVM) confirms that the labels include:

  • AmTech Group Inc. Ketamine Hydrochloride Injection, USP, manufactured by IVX Animal Health Inc..
  • Butler KetaThesia, distributed exclusively by Butler Animal Health Supply, Dublin, Ohio
  • Fort Dodge Ketaset, manufactured for Fort Dodge Animal Health, Fort Dodge, Iowa
  • VEDCO KetaVed, distributed by Vedco Inc., St. Joseph, Mo.
  • Phoenix Ketaject, manufactured for Phoenix Pharmaceutical Inc., St. Joseph, Mo.
  • LLOYD Laboratories VetaKet, manufactured for Lloyd Laboratories in
  • Shenandoah, Iowa
  • RXV Keta-Sthetic, manufactured for RXVeterinary Products, Westlake, Texas
This latest recall stems from the reported death of five cats, inconclusively linked to the drug's use. But troubles within Teva Animal Health surfaced last July, when the FDA shut down the company via a permanent injunction and filed a lawsuit, alleging that regulatory inspectors had uncovered adulterated animal drugs at Teva’s main facilities in St. Joseph, Mo. The generics manufacturer agreed to cease production of its drugs and its DVM Pharmaceuticals line of products following FDA's much-publicized crackdown on the company’s quality control practices.

http://news.vin.com/VINNews.aspx?articleId=14720

To learn more about onsite pharmaceutical material screening solutions, visit: www.xstreamsystems.net.

Friday, May 16, 2008

Drug Safety Responsibility– For whom does the finger point?

The recent heparin recalls have left consumers fuming and pointing fingers at those who were supposedly protecting them from harm. With a difficult past year in both tainted food and medical products – this was the last straw.

But in reality, most in the industry knew the FDA was woefully understaffed and unequipped to cope with the expansion of global inspections required to guarantee the safety of our food and drug supply. Finally this week in answer to Pennsylvania Senator Arlen Spector’s request, FDA commission Andrew C. von Eschenbach asked congress for $275 million as an immediate budget submission. Increased funds will be use to increase inspections, modernize their science and staff, and upgrade their laboratory facilities.

Julie Zawisza, an F.D.A. spokeswoman said “These resources will accelerate the changes required for F.D.A. to protect and promote the health of all Americans in a rapidly changing world that poses new, emerging threats to the safety of food and medical product.”

One might asked, how could we let it get to this point? How indeed! The pharmaceutical industry has a history of relying of reactive testing, specific to the particular contaminant or variance they are guarding against. However, modern day protection requires a more proactive approach – a verification of the whole and an assurance against those criminal minds that can fool testing with traces of authentic material mixed in with the altered substance.

To further this point, we must have testing down the chain as well. As the saying goes, “Test Often, and Test Late!” The closer to consumer that authenticity testing is done, the more you are sure the consumer is receiving the “True Goods”. Too often each company points to the other on whose responsibility it is too safeguard the product.

Now it is the consumer who is doing the pointing and he or she is pointing at us all!

Monday, April 21, 2008

The Secret of CSI: Miami’s Lab

CSI: Miami Cast CSI:Miami draws its viewers to the edge of their seats by spinning out scenarios which catch a criminal and all involved during a day’s work. But how do they do it week after week?

First - you start with a crime lab that would make most real-life crime scene investigators green with envy. The lab boasts modern day tools like mass spectrometry and DNA analysis. The equipment portrayed on the series is very real, but at a cost prohibitive price for most crime labs’ budgets.

Add to the superior equipment, the almost super hero ability to complete tests before the end of day and sometimes within hours. One of these super technicians is Eva LaRue, who plays DNA expert Natalia Boa Vista on the show. She can even extract a single drop of perspiration from a leaf and tell you who was at the crime scene.


Please click the Play button


The reality is lab tests are not completed instantaneously. Once a sample is submitted, it could take weeks for the results to be returned. It is for this reason, screening tests are helpful. These are generally less expensive than outsourcing to an analytical lab and less time consuming.

One industry looking for more efficient screening methods is the pharmaceutical industry. Guarding itself against counterfeits and adulterated medicine is an ever increasing task. They use a variety of security measures currently, but most are focused on the packaging rather than the material itself; such as holograms or special inks.

A viable material screening solution is the XT250 System, which can identify the crystalline structure of a substance by matching it against its standard. By rapidly testing products such as pharmaceuticals in their sealed packages, wholesalers can quickly determine what “passes” and what “fails” industry standards.

CSI: Miami may have the best equipment on T.V., but in real life, the XT250 System is as close as we get to rapid drug authentication.