D-1044-2013 Class II Terminated
FDA drug recall D-1044-2013 was initiated by JCB Labs LLC on August 23, 2013 and is designated Class II. Reason for recall: 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 recall status is terminated (terminated August 18, 2014). Affected quantity: 1056 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- September 25, 2013
- Initiation Date
- August 23, 2013
- Termination Date
- August 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1056 vials
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide and Guam
Code Information
Lot #: 130701@9, Exp 12/28/2013; 130709@6, Exp 01/05/2014; 130717@2, Exp 01/13/2014