Recalls / Class II

Class IID-1044-2013

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.

Affected lot / code info

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

Why it was recalled

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.

Recalling firm

Firm

JCB Labs LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

7335 W 33rd St N, N/A, Wichita, Kansas 67205-9368

Distribution

Quantity

1056 vials

Distribution pattern

Nationwide and Guam

Timeline

Recall initiated

2013-08-23

FDA classified

2013-09-13

Posted by FDA

2013-09-25

Terminated

2014-08-18

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1044-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.