B. Braun Medical Inc., of Irvine on Wednesday announced 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.
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.
Scientific Protein and B. Braun did not return calls seeking comment.
Click here to read the B. Braun announcement that includes lot numbers of drugs.