Product Detail

Product Description Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite Free, 1-mL Single-Use Syringe, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.

Recall Number D-1047-2013

Classification Class II

Code Info Lot # 130806@2, Expiry 09/20/2013.

Product Distributed Qty 1243 Syringes

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