Product: Argatroban Injection 50 mg per 50ml (1 mg per ml)  For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07),  b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc.  Woodcliff Lake, NJ  07677 USA, Marketed by: The Medicines Company, Parsippany, NJ 07054 USA
Reason for recall: A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
Recall initiated: 20111202
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated