FDAFDA · Food and drugs·Recall number D-1429-2012
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
Published August 8, 2012 · Recall initiated: December 2, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Eagle Pharmaceuticals Inc.
- Distributor
- New Jersey
- Lot
- Lot #V10189, Lot #V10191, Lot #V10194, Exp 01/13; Lot #V10223; Exp 02/13
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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