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/.

Johnson & Johnson Faces Possible Criminal Charges

Widely reported by most media outlets, pharmaceutical giant Johnson & Johnson and its McNeil Consumer Products division may face a variety of charges including criminal for what was described by FDA officials in a May 27th Congressional hearing as “a pattern of violations in manufacturing and quality control practices (which) led to a number of recent recalls.

The following are some of the media highlights from yesterday and today:

• ABC World News George Stephanopoulos reported, "Government officials said today they are considering criminal charges against Johnson & Johnson, stemming from last month's huge recall of Tylenol and other popular over the counter children's medicines."

• NBC Nightly News Brian Williams reported, "Johnson & Johnson insists it has taken dramatic steps to clean up the plants where the recalled products are made. Meanwhile, the FDA says it has referred the matter to its criminal division for consideration."

• The New York Times reports, "The Johnson & Johnson unit that recalled millions of bottles of liquid children's Tylenol and other pediatric medicines last month may face criminal penalties, product seizures, or other sanctions, an official from the Food and Drug Administration said Thursday." Notably, the "agency is considering further actions against McNeil Consumer Healthcare...after a pattern of violations in manufacturing and quality control practices led to a number of recent recalls," Sharfstein "said at a Congressional hearing on Thursday."

• The Washington Post states, "When faced last year with Motrin IB caplets that were not dissolving properly, McNeil Consumer Healthcare, a division of Johnson and Johnson, hired contractors to buy the products under orders not to mention the term 'recall,' according to documents released by the House Committee on Oversight and Government Reform." Then, "after the Food and Drug Administration discovered the effort -- because one of the contractors accidentally dropped an instruction sheet on the floor of a store -- McNeil announced a recall of roughly 88,000 packages of the product." And, in the last year, there have been "four recalls of McNeil products...including the April 30 recall of 136 million bottles of infant and children's Tylenol, Motrin, Benadryl and Zyrtec, which have shaken consumers' confidence and threaten to stain Johnson and Johnson's brand name."

• The Los Angeles Times reports that following the revelations at the hearing, "Colleen Goggins, chairwoman of Johnson & Johnson's consumer division, apologized 'to the mothers and fathers and caregivers for the concern and inconvenience' caused by the April recall."

Securing Pharma Chain Blog, supports the inclusion of authentication and verification of pharmaceuticals at all members of the pharmaceutical supply chain to protect against poor manufacturing practices, fraud, adulteration and counterfeiting and avoid consumption of bogus materials by consumers.

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

To read the major media stories, visit:

http://www.nytimes.com/2010/05/28/business/28drug.html?src=busln.

http://www.washingtonpost.com/wp-dyn/content/article/2010/05/27/AR2010052705484.html?hpid=moreheadlines.

http://www.latimes.com/news/nationworld/nation/la-na-tylenol-hearing-20100528,0,1137250.story.

Origin of Our Medicine - Does the Consumer Have a Right to Know?

The following is a summary of an editorial that appeared in the Los Angeles Times about the transparency of the global supply chain and more specifically the pharmaceutical supply chain.

We feel that it is important for the safety and security of the American Consumer to understand the extent of how many global imports affect their health and the need for adequate measures to secure them. Many of the products that we consume in the United States come directly or indirectly from countries whose track record on adulterated raw materials and counterfeit products is incredibly poor. How many contaminated or fraudulent products exist within our supply chain and what can we do to protect ourselves from them?

Before I pop this pill, I'd like to know where it came from
(Summary of an editorial by David Lazarus that appeared in Los Angeles Times March 22, 2009)

In his editorial, David Lazarus discusses the issue of the consumer’s right to know not only where their food comes from, but also pharmaceuticals. To prove his point he follows a rather in depth search for the origins of his Sunmark pain reliever, a generic equivalent of extra-strength Tylenol.

He shares with his readers some interesting little know facts he learned along his quest, for instance:

“What I did learn, though, is that more than half of the world's aspirin now comes from China, as does more than a third of acetaminophen and almost all synthetic vitamin C. Chinese drug imports into the United States top $700 million a year.”

He uses two recall examples to emphasis why consumers should be aware of where their medicines originate. One is the recent recall of heparin that occurred last year after more than a dozen deaths. In this case an adulterated ingredient was traced back to Shanghai, China. The second is a recall which occurred in 2006 by Perrigo, one of the world's largest manufacturers of store-brand over-the-counter medicines. Perrigo recalled 11 million bottles of acetaminophen sold under various brands due to small metal fragments which were discovered in some batches. The cause was stated as raw materials obtained from a third party, but Perrigo would not comment on the name or location of the party.

Finally, he gives his suggestions on what he sees as critical information that should be listed on each label. This is necessary in his opinion because as he states: “I'm not saying that drug makers should be required to do everything in-house. But as a consumer, I'm entitled to know exactly what I'm putting in my mouth and how it got there.”

To view the entire editorial, visit the Los Angeles Times at www.latimes.com.