NEW YORK (Associated Press) - A day after Baxter International Inc. recalled nearly all remaining batches of its blood thinner heparin, a report Friday linked the product to additional patient deaths.
Late Thursday, Baxter said it will recall all remaining lots of heparin single- and multi-dose injections and HEP-LOCK products. The company recalled nine production lots of heparin multi-dose injection in January after the drug was linked to four deaths and hundreds of allergic reactions.
On Friday, the New York Times reported that the Food and Drug Administration had discovered possible links to 17 other deaths. The paper added that the agency is focusing on a Chinese plant that supplies the active ingredient in heparin, which is made from mucous membranes extracted from pig intestines.
In a letter posted to the FDA Web site Thursday, the FDA discussed problems in the manufacturing process. It said some lots of heparin sold in the U.S. "included material from an unacceptable workshop vendor," among other issues.
While the FDA investigation is not complete, Goldman Sachs analyst Lawrence Keusch said there was reason to believe the problem was linked to the Chinese plant, Changzhou SPL.
"Baxter and the FDA have ruled out any issues at the company's Cherry Hill, New Jersey, finishing facility," he said. He added that the only form of Baxter's heparin left on the market is a premixed IV solution, which is not sourced from China.
Keusch said the expanded recall is not a surprise, and won't have much impact on Baxter.
"From a financial perspective, heparin sales were roughly $30 million in 2007, and with a gross margin of 20 percent are not material to earnings," he said.He added the recall is unlikely to affect other Baxter product, because only a few of its minor products are processed in China, and none are made at the facility cited by the FDA.
tag: FDA Recall, drug recall, Changzhou SPL, heparin, HEP-LOCK products, Baxter International recall,