Nearly two dozen lots of a commonly used blood thinner are being recalled across the United States after foreign matter was discovered, according to a notice published by the Food and Drug Administration (FDA) last week.
The pharmaceutical company Par Health is recalling 22 lots of Argatroban injection, in 250 mg/2.5 mL or 100 mg/mL solutions, at both the hospital- and user-level, the Oct. 14 notice said.
The reason provided by the company is “particulate matter” that was determined to be cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel that was found in the intravenous solution.
If the drug is administered, there is a “reasonable probability” of the contaminated solution “causing life-threatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or inflammation of the walls of veins, which may lead to clotting,” according to a company news release….