Drug 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
D-1429-2012
Product summary
- Event
- Event 61108
- Status
- Terminated
- Classification
- Class I
- Quantity
- 19,660 vials
- Official record key
drug-enforcement:D-1429-2012
Official wording
Reason: 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.
Code information: Lot #V10189, Lot #V10191, Lot #V10194, Exp 01/13; Lot #V10223; Exp 02/13
Distribution pattern: New Jersey
Derived failure modes
-
Foreign material or chemical contamination
particulates