Particulate Matter Contamination Leads to Argatroban Recall

Four lots of the blood thinner Argatroban have been recalled due to particulate matter contamination. 

The Argatroban recall was announced by the FDA on March 23, after visible particles were spotted in some vials during inspections that occurred after the distributor received a complaint. The recall was issued by Eagle Pharmaceuticals, Inc., supplier to The Medicines Company.

Argatroban is an anticoagulant used to prevent or treat thrombosis caused by the drug heparin. It was first approved by the FDA in 2000.

The FDA warns that the risk of using an injectable drug that has been contaminated with particulate matter could include embolization and infarction to organs, which could cause severe injury. There have been no reports of injuries related to the recalled Argatroban.

Four lots of Argatroban Injection, 50 mg per 50 mL, are affected by the recall, including lot numbers V10189, V10191 and V10194 with expiration dates of Jan 2013, and lot number V10223 with an expiration date of Feb 2013.

Eagle Pharmaceuticals Inc. has asked The Medicines Company to arrange for the affected vials to be returned from services and facilities that received them. The recall is being conducted at the wholesaler, pharmacy and distributor levels.

Customers with questions can contact The Medicines Company at (888) 977-6326 or via e-mail at argatrobanrecall@themedco.com. Adverse events related to the use of this product should be reported to the FDA’s adverse event reporting program, MedWatch.