Drug recall D-831-2013

Class II Terminated reported Aug 7, 2013

Product

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

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.

Lots and codes

Product Code: L5B4826, Lot #: C886820, Exp 11/14

Recall details

Recalling firm
Baxter Healthcare Corp., Deerfield, IL
Quantity
39,486 containers
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
July 24, 2013
Terminated
June 24, 2014

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