CLASS II Drug recall · Reported 7 Aug 2013 · FDA Enforcement Report
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis recalled
Baxter Healthcare is recalling Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose container, distributed nationwide in the US. The recall was initiated on 24 Jul 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-831-2013
- FDA event ID
- 65784
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Manufacturer
- Vantive US Healthcare LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2013
- FDA classified
- 1 Aug 2013
- Reported
- 7 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Jul 2013 | Recall initiated by company | |
| 1 Aug 2013 | Classified by FDA | +8 days |
| 7 Aug 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it 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.
Which lots are affected?
Product Code: L5B4826, Lot #: C886820, Exp 11/14
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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