Enforcement Report - Week of August 8, 2012
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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 |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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 | Lot #V10189, Lot #V10191, Lot #V10194, Exp 01/13; Lot #V10223; Exp 02/13 | Class I | 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. | 19,660 vials | D-1429-2012 |
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