Baxter recalls remaining heparin vial products
LOS ANGELES (Reuters) - Baxter International Inc said on Thursday it was voluntarily recalling all remaining lots of its heparin injection and flush products now that U.S. regulators have concluded there is sufficient capacity from other suppliers.
The company initially recalled nine lots of multi-dose vials of the blood thinner in mid-January after a higher than usual number of reports of adverse patient reactions.
Baxter suspended production of multi-dose vials of the drug earlier this month while officials search for the cause of four deaths and hundreds of health problems reported in patients.
The U.S. Food and Drug Administration has admitted it never inspected a Chinese plant that supplies an active ingredient for Baxter's heparin before approving it because it mixed up the name with that of another company.
FDA officials have said it is unclear if the Chinese site is linked to the potential reactions, which include breathing difficulty, vomiting and rapid drops in blood pressure.
The agency previously said it planned to start an inspection last week of the plant in Changzhou, China, which is owned by Wisconsin-based Scientific Protein Laboratories LLC (SPL).
FDA officials have said it is agency policy to inspect all manufacturing sites before granting a drug approval and that the heparin plant mix-up was an isolated case.
"We have assurance from the U.S. Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs," Peter Arduini, president of Baxter's medication delivery business, said in a statement.
Baxter said its recall does not involve heparin premixed intravenous solutions in bags.
(Reporting by Deena Beasley, editing by Phil Berlowitz)
