NEW YORK B. Braun Medical Inc. on Friday said it is recalling 23 lots of its blood thinner after being notified by its supplier of a nationwide recall of Heparin Sodium USP because of a contaminant.
B. Braun Medical, of Irvine, California, began recalling the lots on March 21 as a precautionary measure, after Scientific Protein Laboratories said that one lot of Heparin Sodium, USP Active Pharmaceutical Ingredient it bought has a heparin-like contaminant.
So far B. Braun Medical Inc. has not received any adverse event reports related to this issue.
The U.S. Food and Drug Administration has received reports of serious injuries and/or deaths in patients who have been administered heparin injectable products of other companies containing this contaminant.
On Thursday, American Health Packaging, a unit of AmerisourceBergen Corp, said it was voluntarily recalling 1,421 units of heparin injection vials as part of Baxter International Inc's broader recall of heparin products.
The vials were manufactured by Baxter and then placed by American Health Packaging into individually labeled bags for use in pharmacy automation equipment.
U.S. health regulators have identified a contaminant found in batches of Baxter's blood-thinner heparin that were linked to serious reactions and up to 19 deaths. The heparin was supplies by a plant in Changzhou China, co-owned by Wisconsin-based Scientific Protein Laboratories LLC.
(Reporting by Ilaina Jonas; Editing by Christian Wiessner)