Product Detail

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.

Recall Number D-1044-2013

Classification Class II

Code Info Lot #: 130701@9, Exp 12/28/2013; 130709@6, Exp 01/05/2014; 130717@2, Exp 01/13/2014

Product Distributed Qty 1056 vials

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.

Event Detail

Event Id 66099

Product Type Drugs

Status Ongoing

Recalling Firm

City Wichita

State KS
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-08-23

Initial Firm Notification of Consignee or Public Telephone

Distribution Pattern Nationwide and Guam