Product Detail

Product Description Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.

Recall Number D-1045-2013

Classification Class II

Code Info Lot # 130620@2, Exp 12/17/2013

Product Distributed Qty 397 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

JCB Labs LLC
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