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U.S. Department of Health and Human Services

Enforcement Report - Week of April 1, 2015

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Product Detail

Product Description 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03
Recall Number D-0425-2015
Classification Class II
Code Info Lot #: C929844, Exp 5/31/2015; C926873, Exp 4/30/2015; C928630, Exp 4/30/2015.
Product Distributed Qty 597,498 units total
Reason For Recall Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

Event Detail

Event Id 70770
Product Type Drugs
Status Ongoing
Recalling Firm Baxter Healthcare Corp.
City Deerfield
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2015-03-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide