FDA-Drug2013-09-25Class II
Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories, Wichita, KS.
JCB Labs LLC
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.
Sold states
Nationwide and Guam
Affected count
677 vials
Manufactured in
7335 W 33rd St N, N/A, Wichita, KS, United States
Products
Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories, Wichita, KS.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1046-2013Don't want to check this manually?
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