Enforcement Report - Week of August 8, 2012
-
Back to Previous Page
Product Detail
| Product Description | 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 |
|---|---|
| Recall Number | D-1429-2012 |
| Classification | Class I |
| Code Info | Lot #V10189, Lot #V10191, Lot #V10194, Exp 01/13; Lot #V10223; Exp 02/13 |
| Product Distributed Qty | 19,660 vials |
| 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. |
Event Detail
| Event Id | 61108 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Eagle Pharmaceuticals Inc. |
| City | Woodcliff Lake |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-12-02 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | New Jersey |
-
