U.S. health officials evaluated the wrong factory when assessing the safety of a Chinese-made drug ingredient that may be a source of problems with a blood thinner, the Food and Drug Administration said Monday.
Baxter International's heparin has been linked to four deaths and hundreds of allergic reactions. An investigation will take FDA inspectors to China this week.
The Chinese manufacturer was not inspected because it was confused with another company in the agency's database with a similar name, said Joseph Famulare, deputy director of the Center for Drug Evaluation and Research's compliance department. The FDA evaluated that firm, which had a history of positive inspections and was not reinspected.
The agency discovered in the past month that the wrong factory was evaluated, Famulare said, adding that as far as the FDA knows, it is an isolated incident.
Investigators will travel to China this week to inspect the company that produces the drug's active ingredient.
The agency doesn't know what is causing the deaths and allergic reactions. The FDA told doctors last week to stop using Baxter's heparin.