FDAClass IIAugust 7, 2013

DIANEAL Low Calcium recall

DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield…

Why was DIANEAL Low Calcium recalled?

Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield…
Recalling firm
Baxter Healthcare Corp.
Quantity
39,486 containers
Distribution
Nationwide and Puerto Rico
Recall date
August 7, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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