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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Product Detail

Product Description DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07
Recall Number D-831-2013
Classification Class II
Code Info Product Code: L5B4826, Lot #: C886820, Exp 11/14
Product Distributed Qty 39,486 containers
Reason For Recall Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.

Event Detail

Event Id 65784
Product Type Drugs
Status Ongoing
Recalling Firm Baxter Healthcare Corp.
City Deerfield
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico
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