The FDA is also unsure if other heparin products used in the United States or other countries contain this contaminant, Woodcock said. The FDA will be releasing data on how companies can screen heparin for this contaminant, she said.
Following Wednesday's teleconference, Scientific Protein Laboratories released a prepared statement that said it was "premature to conclude that the heparin active pharmaceutical ingredient (API) sourced from China and provided by SPL to Baxter is responsible for these adverse events."
"During the call with the media, FDA speculated that the source of the adverse events may be a contaminant. It is important to note that this theory is speculation at this point, and SPL is participating actively in working with the FDA to pursue this theory, as well as others, so that we can understand the cause of the adverse events," the statement said.
Contaminated products from China have been an ongoing worry for the FDA. If the heparin contamination turns out to be deliberate, it would be reminiscent of last year's scandal when a Chinese company was charged with adding the toxic chemical melamine to an ingredient used in U.S. pet food that killed thousands of dogs and cats. The melamine let the ingredient pass chemical inspections for protein content, the Associated Press reported.
On Feb. 28, Baxter Healthcare, of Deerfield, Ill., which had provided about half the nation's supply of heparin, announced it was recalling any remaining multi-dose vials of heparin as well as single-dose heparin vials. The company also recalled its Hep-Lock heparin flush products, which include a small amount of heparin and are used to prevent blood clots in intravenous lines.
The recall was made possible because the other manufacturer of multi-dose heparin vials, APP Pharmaceuticals of Schaumburg, Ill., was able to assure the FDA that they could meet all the demand in the United States.
At that time, the FDA also said it had completed its inspection of Scientific Protein Laboratories' Changzhou SPL plant. The plant was no longer producing heparin, inspectors found. The inspectors did find deficiencies in the way the plant removed impurities and dealt with testing results that didn't meet specifications. In addition, they found problems in waste disposal and equipment, according to the FDA.
