Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories, Wichita, KS.

Recall Number: D-1046-2013

Firm: JCB Labs LLC

Classification: Class II

Status: Terminated

Report Date: 20130925

Initiation Date: 20130823

Termination Date: 20140818

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories, Wichita, KS.