B Braun Recalls Possibly Tainted Heparin

Recall linked back to the 2007/2008 Heparin crisis that poisoned hundreds.

Andrew Zajac from the Los Angeles Times is reporting about the recent announcement by B. Braun Medical Inc., of a recall of seven lots of the anticoagulant heparin because of concerns they may be contaminated with trace amounts of oversulfated chondroitin sulfate, or OSCS, the same substance implicated in the 2008 heparin crisis that killed or seriously sickened dozens of people.

According to the Mr. Zajac’s report:

• The company said in a statement that based on current information, the recalled lots did not pose a significant health risk, but they're being pulled from the market "with the support of the U.S. Food and Drug Administration."

• "There is not a significant public health threat," FDA spokeswoman Karen Riley said.

• The active ingredient in the suspect heparin was manufactured by Scientific Protein Laboratories Inc. of Waunakee, Wis., the same company that supplied the active ingredient for the heparin distributed by Baxter International that poisoned hundreds of patients in late 2007 and early 2008.

• Riley said B. Braun's announcement reflected a decision by Scientific Protein to recall three lots of the heparin ingredient that were distributed to manufacturers in the United States, Canada and Japan. It was not immediately clear how many, if any, other manufacturers are affected by the recall.

• Both the heparin in the poisonings and in the B. Braun recall were manufactured with raw material – pig intestines – from China. An FDA-led inquiry at the time of the heparin crisis identified OSCS as the contaminant. The substance apparently was added in an effort to stretch heparin, which is subject to significant fluctuations in supply because of changes in the Chinese pig population.

• The FDA has not identified who was responsible for the adulteration, or where in the lengthy Chinese supply chain it occurred. The heparin in the B. Braun recall also is from the same batch discussed in a recent FDA inspection that found that Scientific Protein waited a year to investigate a complaint about possible OSCS contamination.

• Riley said the heparin ingredient was manufactured by Scientific Protein in 2006 and was determined to contain traces of OSCS by one of the company's medical industry customers, which called it to the company's attention in October 2008.

• Scientific Protein's "quality department did not initiate a formal investigation into this complaint until 9/9/09," according to the FDA inspection report. It's not clear whether the complaining customer was B. Braun.

Many of the facts of this incident remain to be seen and or made public. It is anticipated that there will be more voluntary recalls and information over the next several days.

Secure Pharma Chain is puzzled with this recent turn of events given the amount of scrutiny that the 2007/2008 Heparin crisis elicited within the government, industry and consumers world wide. It would appear that not all the bases were covered within the supply chain following the deaths of some many back in 2007/2008.

Secure Pharma Chain encourages all within the supply chain to avoid the issues of fraudulent, adulterated, sub-standard and counterfeit drugs by deploying authentication technologies to verify that their inventories are safe and efficacious.

To read the entire story, visit: http://www.chicagotribune.com/health/la-heb-heparin-recall-braun-20101027,0,2834227.story

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

Dallas Morning News: Investigation Reveals That Chinese Government "Hampered" FDA Probe of Tainted Heparin

In a follow up to a previous posting on a July 23rd posting of a Pharmalot.com blog, The Dallas Morning News in its Trail Blazers Blog continues the reporting on Congress questioning the FDA on their ability to work with the FDA on the Tainted Heparin probe.

According to the Dallas Morning News Trailblazer Blog:

"An investigation by Reps. Joe Barton and Michael Burgess has found that the Chinese government had 'severely hampered' a Food and Drug Administration probe into contaminated heparin." They wrote to FDA commissioner Dr. Margaret Hamburg, saying that "FDA officials informed them in June that the agency was 'denied full access to manufacturing and laboratory facilities,' nor were they allowed to review records." Notably, the "FDA investigation focuses on a batch of tainted heparin, a popular blood thinner that was linked to at least 81 deaths in 2007 and 2008."

The continued exposure of the lack of Chinese cooperation reveals to everyone within the pharmaceutical supply chain that there are many significant gaps in the ability of regulatory authorities to control and enforce the quality of medications that are now such a prevalent part of the pharmaceutical supply chain.

Secure Pharma Chain encourages industry supply chain leaders to take appropriate measures and deploy technologies that protect their brand, secure their inventories, differentiate themselves in the marketplace and most importantly save from harm consumers who take these medications.

To view the Dallas Morning News blog, visit: http://www.trailblazersblog.dallasnews.com/.

Breitbart: China Faces New Health Scare Over 'Bad Vaccines'

In a story posted on Breitbart.com, the various recent incidents of fraudulent, mis-handled, adulterated and counterfeit consumer products that have negatively impacted the healthcare of the Chinese consumer is chronicled.

Several of these deadly stories of corruption and greed have been previously reported in Secure Pharma Chain Blog.

This is an excellent read for the uninitiated as it relates to the dangers that exist when supply chains are not tightly controlled, regulated and enforced.

The stories of fraudulent vaccines, tainted Heparin, poisoned baby formula and various other deadly consumer products are all too commonplace in China. It would appear to the casual observer that instead of being isolated incidents these incidents of deadly consumer products seem to be on the rise.

Of concern to many is the fact that as the global economy expands, the reality is that a good many of the products that are consumed around the globe have raw materials and/or are manufactured in China. These products are now part of the various supply chains and can be found on the shelves of retailers everywhere.

Secure Pharma Chain Blog encourages industry leaders, governments and consumers require that the inventories of the supply chains that service their basic needs of food, medications and other goods are safe, secure, authenticated and fit for consumption.

To learn more about supply chain material authentication solutions, visit: http://www.xstreamsystems.net/.

To read the entire story, visit: http://www.breitbart.com/article.php?id=CNG.1b07d1be69ebdf895fab113ba26ecde7.321&show_article=1.

Up to 30 per cent of EU generics 'contain falsified APIs'

On Friday, SecuringPharma, published an interesting article on the quality of active pharmaceutical ingredients (APIs) in European generics.

The European Fine Chemicals Group claims that 20 to 30 percent of the APIs come from unapproved sources.

EFCG board member Guy Villax quoted that figure, which he attributed to EU inspectors, at a press conference at the Conference on Pharmaceutical Ingredients (CPhI) held last week in Madrid, Spain.

This causes a huge challenge to the validity and efficiency of the finished product as a single batch of an API can reach from 10,000 to 1,000,000 patients. Currently a manufacturer receives Good Manufacturing Practice (GMP) certification based not only on their own practices, but those of their suppliers as well. If their suppliers are in reality not as they have stated, you can see how this circumvents the inspection process.

Council of Europe is drafting legislation on counterfeit medicines to be reviewed by 40 countries. However, EFCG does not agree with the current wording of the EU's draft directive which suggests that API manufacturers can be inspected by their own domestic authorities, providing their enforcement systems are deemed 'equivalent' by the EU, i.e. they conform to ICH Q7 and are based on regular inspections.

This would work with countries such as the USA, Japan and Australia, said Villax, but he is concerned that equivalence could be granted for political reasons to other countries where the systems may be prone to fraud and corruption.

We at XStream Systems agree that the quality of the finished product is only as good as the quality of the ingredients that are contained therein. In the United States this was only too evident in last year’s case of tainted heparin, where the active ingredient had been tainted by unapproved suppliers and resulted in the death of over 80 people.

To view the entire article visit: www.securingpharma.com.

Chinese Heparin Producers Get Warning Over Falsified Information

FDA issues letters to two more Chinese manufacturers regarding tainted Heparin

It reads like a bad sequel as more companies have been named in the tainted heparin scandal…

Two Chinese companies have been issued warnings from the FDA for falsifying information on Heparin. Shanghai No. 1 Biochemical & Pharmaceutical said they were manufacturing heparin, when in fact they were purchasing it from two outside companies. One supplier is no longer producing the medicinal product.

The other supplier, Qingdao Jiulong Biopharmaceuticals was also given a warning letter. Jiulong was found to have produced 19 lots of heparin contaminated with Over-Sulfated Chondroitin Sulfate (OSCS), a substance implicated in the U.S. deaths last year. The FDA further faulted them for not investigating how the substance got into the blood thinner and for exporting medicinal products without regulatory approval.

This warning letter was in response to the FDA’s inspection of Jiulong in August 2008. Jiulong told investigators that they did not ship directly to the United States. However, during inspections at U.S. facilities purchase orders were discovered indicating that the plant had been shipping heparin sodium to the U.S. since 2005. FDA also stated that in the past, the firm supplied heparin to Amphastar Pharmaceuticals Inc., a California company that supplies pre-filled syringes.

This story illustrates why analytical screening should be conducted throughout the supply chain – to ensure the quality of: those products supplied to your company, those products you supply to others, and ultimately the finished product consumed by the patient.

Baxter CEO Says Heparin Purposely Tainted

Yesterday on Capitol Hill, a house subcommittee heard testimony on the recent issue of contaminated Heparin. Robert Parkinson, CEO of Baxter testified that the company believes the heparin was deliberately tainted.

Most heart wrenching, was when the family’s victims told their stories on how the tainted Heparin has destroyed their lives.

Leroy Hubely, was in tears as he explained how his wife Bonney died in December 2007 and then a month later his son, Randy died under the same circumstances. Only after the recall of Heparin, did he learn from his local dialysis center that tainted heparin, and not some cruel twist of fate, led to both of their deaths.

His daughter-in-law Collen Hubely, a dialysis nurse, testified: “As a nurse, I thought that I would be there to save my husband from any errors, but I guess I was naive. I never thought the life saving medication we were relying on might be contaminated. If citizens are truly going to ever to feel safe in this country going to the hospital, a doctor, taking your daily medication; we have a responsibility to be make sure that everything that is given is free from contamination.”

Families demanded more stringent policies and testing to protect consumers from dangerous materials hidden in our medications.