drugs Class II Updated 2013-09-25

JCB Labs LLC recalls Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 130701@9, Exp 12/28/2013; 130709@6, Exp 01/05/2014; 130717@2, Exp 01/13/2014
View official government recall

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