FDA recall D-1429-2012

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.

Distribution

New Jersey

Key facts

Status

Terminated

Initiation date

2011-12-02

Report date

2012-08-08

Termination date

2013-06-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Woodcliff Lake, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1429-2012