FDA Recall D-1429-2012
Eagle Pharmaceuticals Inc. · Woodcliff Lake, NJ
Class I — life-threatening Terminated 549 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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 record
- Recall number
D-1429-2012- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- New Jersey
- Recall initiated
- 2011-12-02
- Classified by FDA Center
- 2012-07-31
- FDA published
- 2012-08-08
- Terminated
- 2013-06-03
- Recalling firm
- Eagle Pharmaceuticals Inc.
- Firm location
- Woodcliff Lake, NJ