FDA recall D-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.

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

Nationwide and Guam

Key facts

Status

Terminated

Initiation date

2013-08-23

Report date

2013-09-25

Termination date

2014-08-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wichita, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1044-2013