FDA Posts Nationwide Recall of Par Health Argatroban Injection After Particles Found in 22 Lots
The U.S. Food and Drug Administration (FDA) on October 14 posted a nationwide recall of 22 lots of argatroban injection by Par Health, recalled down to the hospital and user level. The company had announced the recall on October 13.
The recall was issued after particulate matter was found in the product, including cellulose, polystyrene, polyethylene terephthalate (PET), vial-stopper material and even stainless steel particles. Foreign particles in an injectable drug can pose risks such as blood-vessel blockage. The company said it had received no adverse-event reports related to the recall as of the announcement.
Argatroban is an anticoagulant used to treat patients with heparin-induced thrombocytopenia. The FDA advises hospitals and patients holding the affected lots to check the lot numbers in the notice and stop using the product; the full lot list is on the FDA's recall page.
Published by GSM · USA (original Chinese edition)
Photo: 图：医护人员演示静脉输液操作。摄影：美国海军，公共领域，来源：Wikimedia Commons / Photo: A corpsman demonstrates inserting an intravenous drip. Credit: U.S. Navy, public domain, via Wikimedia Commons
