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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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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 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