FDAFDA · Food and drugs·Recall number D-1046-2013
Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories, Wichita, KS.
Published September 25, 2013 · Recall initiated: August 23, 2013
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
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- JCB Labs LLC
- Distributor
- Nationwide and Guam
- Lot
- Lot # 130710@4, Exp. 01/06/2014
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.