Yesterday, the FDA seized 11 lots of Heparin products, valued at approximately $112,000, which were found to be contaminated with over-sulfated chondroitin sulfate (OSCS) from Celsus Laboratories in Cincinnati, Ohio. All 11 lots were manufactured with material imported from China, although the FDA reported that the contaminated crude heparin entered the United States prior to the import ban in April 2008. The discovery was found as part of the cooperative efforts by manufactures and the FDA to perform additional testing on all heparin materials to ensure no OCSC contamination. In fact, Celsus informed CNN that these lots had been quarantined by Celsus since March 8, 2008.

The FDA previously reported recalls of heparin products from Celsus Laboratories because of finding that batches of crude heparin Celsus received from their supplier contained OCSC. Celsus was also reprimanded by the FDA earlier this year for insufficient efforts by Celsus to notify its customers about the contaminated heparin products.

Celsus is a private business that has been manufacturing heparin related products, among others, since 1987. It not only provides its products here in the U.S., but also exports to many other countries, such as Australia, Canada, the European Union, and Japan.

Correction to reflect updated information:

USA Today originally reported that the contaminated heparin was imported from Changzhou SPL, the Chinese arm of U.S. based Scientific Protein Labs. USA Today cited FDA Spokeswoman Karen Riley for that information. They have now corrected their story to eliminate SPL as the source of the contaminated heparin after I brought this claim to the attention of the SPL attorney. Celsus had never been listed before as a customer of SPL or CZSPL. It is not clear whether the FDA spokesperson was misunderstood by USA Today, or if the FDA spokesperson was simply wrong as to the source of the contaminated product. Certainly the FDA should clarify this and should announce, publicly, the source of the OSCS contaminated heparin utilized by Celsus.

The FDA says it inspected Celsus Laboratories in April and found that two of its heparin products were contaminated.

The company had sent a letter to its customers telling them its heparin was contaminated, but FDA wanted the company to physically recall the product because of the danger it presented to patients.

FDA sent a follow-up letter to the company again asking for a recall on May 8.

What the federal marshals did Thursday was to seize the contaminated heparin that remained at the company's facilities, Riley says.

Comment: There is nothing in this latest story to establish that importations of contaminated heparin have occurred since April of 2008. But the story does show a conscious disregard by Celsus for the health and safety of the consumer. The FDA should have more power so that they can enforce the recall of these products.

In my opinion the FDA should also focus on inspection of existing health care facilities in this country to insure that all the bad stuff is off the shelf. I am personally more concerned about seizure of existing product in the hands of health care providers than raids to recover product that has already been quarantined.

And I want to know if Celsus used any of the contaminated Heparin in any of the products it shipped since April.

It is going to take much more than this raid to convince Americans that the FDA is doing its job; however the fact that Celsus chose to ignore the FDA request for a recall shows that Celsus has failed to act responsibly and has instead shown callous disregard for the consumer.

UPDATE COMMENT: Celsus should immediately disclose the source of the contaminant. Was Celsus experimenting with the use of OSCS? Did it know the products it sold contained OSCS? Celsus, up to now, has had a very good reputation. Its web site, www.heparin.com states:

Celsus is pursuing the development of a proprietary complex carbohydrate comprising a rare disaccharide sequence that may be prepared by chemical synthesis, genetically modified organism or site selected 6-O-sulfation of dermatan sulfate for medical needs unmet by heparin or its low molecular weight derivatives.

Celsus owes the world an explanation.

Labels: Baxter Heparin, Celsus, FDA, OSCS, over sulfated chondroitin sulfate