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 250 mg/2.5 mL (100 mg/mL) at 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.
A list of lots and expiration dates can be found on the FDA website, which says the affected products were sent to distributors and hospitals between Dec. 30, 2024, and May 5, 2026.
The news release said the company will send “written notification to wholesale and hospital accounts that have received the affected lots and is arranging for return of all existing inventory” through Inmar, Inc. Wholesale distributors and hospital pharmacies should stop using the product and stop distributing the injections, the release said.
Adverse reactions or issues with quality should be reported to the FDA’s MedWatch Adverse Event Reporting program, according to the release. The company also provided phone numbers and emails for consumers.
The FDA did not classify the recall, which would indicate how serious it is, the release said. It did not say how many units of the drug were under recall and only listed the number of lots.
Argatroban is a prescription-only medication that prevents and treats blood clots, belonging to a type of drug known as blood thinners, the Cleveland Clinic says on its website.
The medication is also used to treat blood clots in people with bleeding problems caused by another medicine, heparin, according to the Mayo Clinic. It can also be used in patients undergoing certain heart and blood vessel procedures, such as coronary angioplasty.
About two months ago, another type of blood thinner medication was recalled in a separate action. Dabigatran etexilate capsules manufactured by India-based Alkem Laboratories Ltd. were recalled due to “failed impurity/degradation specification,” a notice stated.
