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/.

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.

Recent Adulteration of Heparin Drives Newly Proposed USP Standards

This month the U.S. Pharmacopeia (USP) proposed a second revision to their standards for the blood thinner, Heparin. This measure is to increase patient safety particularly because adulterated heparin resulted in the reported deaths of more than 200 patients worldwide in 2007 - 2008.

Most standards tests are generated to ensure manufacture quality and not equipped to look at unknown contaminants that may be added deliberately—as was the case with heparin. In the recent heparin recall the drug was adulterated with over-sulfated chondroitin sulfate and was not detected by current methods available then.

While we applaud the USP for answering this new threat to our citizen’s health, it does indicate that our pharmaceutical security measures need to be more proactive rather than reactive. Current science now offers methods to scan products to alert the user of unknown contaminants through the use of EDXRD technology. For more information on this revolutionary solution, visit: www.xstreamsystems.net.

To read more on the proposed USP revisions visit: http://www.usp.org/pdf/EN/aboutUSP/heparinStatement.pdf

For more information on specific changes to the monograph standards, visit www.usp.org or contact mediarelations@usp.org.