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U.S. Department of Health and Human Services

Enforcement Report - Week of July 9, 2014

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Product Detail

Product Description Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61.
Recall Number D-1413-2014
Classification Class II
Code Info Lot #: C926923, Exp 01/16
Product Distributed Qty 20,810 containers
Reason For Recall Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.

Event Detail

Event Id 68577
Product Type Drugs
Status Ongoing
Recalling Firm Baxter Healthcare Corp.
City Deerfield
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-06-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide