JCB Labs LLC recalls Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories,
Recalled September 25, 2013 · FDA recall D-1046-2013 · JCB Labs
Hazard
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. · FDA Class II
Units
677 vials
Sold at
Nationwide and Guam
Description
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.
Product
Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories, Wichita, KS.
Manufacturer(s)
JCB Labs LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →