FDAFDA · Food and drugs·Recall number D-1044-2013
Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection, 50 mL Single Dose Vial, 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 #: 130701@9, Exp 12/28/2013; 130709@6, Exp 01/05/2014; 130717@2, Exp 01/13/2014
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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