Baxter extends heparin recall; FDA investigates Chinese supplier
|Baxter broadens its recall of Heparin. Source: ABC News|
Baxter has extended its recall from the multi-dose vials of heparin sodium for injection to include single-dose vials of heparin sodium for injection; and as a precautionary measure, the pharmaceutical company is also recalling its heparin lock flush products.
The company initially recalled nine lots of heparin sodium injection multi-dose vials on Jan. 17 as a precautionary measure due to a higher than usual number of reports detailing adverse patient reactions with the product, and suspended production earlier this month.
The FDA has reported that the number of deaths potentially associated with the drug has risen from four to 21.
The New York Times reported today that the FDA is investigating two Chinese wholesalers, or consolidators, that supplied crude heparin to the Chinese plant, Changzhou SPL, as well as those that sold raw ingredients to the consolidators.
At least one of the consolidators received supplies from small, unregulated family workshops that scraped mucous membrane from pig intestines and cooked it, eventually producing a dry substance known as crude heparin, according to the NY Times.
As CVB News reported last week, the FDA failed to inspect Changzhou SPL because of a paperwork error in which regulators confused the factory's name with another that already had U.S. approval. The Chinese regulatory agency also did not inspect the plant.
Scientific Protein Laboratories, based in Waunakee, Wis., the majority owner of the Chinese plant, issued a statement Thursday saying the FDA’s finding did not represent its final determination as to whether the plant complied with federal regulatory rules.
Last week, the agency began to investigate the plant. The FDA has said that the underlying cause of adverse events are still unknown and its investigators and scientists are working independently and in collaboration with the Centers for Disease Control and Prevention and Baxter to discover the underlying cause of the adverse events.
“We will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue,” said Peter J. Arduini, president of Baxter's medication delivery business.
Since the FDA learned of the adverse events associated with the Baxter multi-dose heparin vials, the agency said that its Drug Shortages Team has been working with APP Pharmaceuticals and other U.S. suppliers for heparin multi-dose and single-dose vials, to determine their manufacturing capacity. The agency said that other heparin producers are expected to be able to increase heparin production sufficiently to supply the U.S. market.