Status
Terminated
Drug Enforcement D-1429-2012
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.
Classification
Class I
Report Date
August 8, 2012
Termination Date
June 3, 2013
Product Information
- 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
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- New Jersey
Location & Firm
- Recalling firm
- Eagle Pharmaceuticals Inc.
- Address
-
470 Chestnut Ridge Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1429-2012
- Event ID
- 61108
- Recall initiation date
- December 2, 2011
- Center classification date
- July 31, 2012
- Code info
- Lot #V10189, Lot #V10191, Lot #V10194, Exp 01/13; Lot #V10223; Exp 02/13
- More code info
- —