Heparin Syringes Might be Contaminated, Covidien Ltd. Warns
Another company, Covidien Ltd., has recalled a heparin product. Covidien announced a recall of its prefilled syringes containing heparin on Friday, after the company said it was informed by its supplier, Scientific Protein Laboratories, that two lots of Heparin Sodium USP active pharmaceutical ingredient it received might contaminated with the same chemical recently found in heparin recalled by Baxter Healthcare over the past few months. Scientific Protein Laboratories also supplied a contaminated ingredients to Baxter for its heparin, which has been linked to more than 700 serious reactions and possibly 19 deaths among patient in the US.
Earlier this month, the FDA determined that Baxter heparin had been tainted with an ingredient derived from animal cartilage. The substance, chondroitin sulfate, had been molecularly changed to mimic the blood clotting properties in heparin’s active ingredient. Baxter procured the active ingredients for its heparin from Changzhou SPL, a Chinese facility partially owned by Scientific Protein Laboratories. Changzhou in turn buys its heparin from two companies, called consolidators, that gather crude heparin from workshops that make it from pig intestines. Many Chinese workshops that make crude heparin are unregulated family operations.
The FDA has yet to determined if the ingredient substitution was intentional, but heparin producers in China also sell chondroitin sulfate, which can be derived from pig cartilage. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs. China has been the point of origin for many drug contamination and counterfeiting scandals. Recently, it appears that the Chinese have taken steps to crack down on heparin producers. On March 21, the Chinese State Food and Drug Administration issued an order in a notice its Web site requiring heparin producers to obtain the raw chemicals used to make the drug from registered suppliers. Raw heparin suppliers in that country are now required to improve their management and tests on their products, it said. This was a reversal of the Chinese government’s earlier position, as the agency had insisted that ensuring the quality of exported chemicals like heparin was the responsibility of importers and importing countries.

