US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Jun 17, 2024 (2 years ago)

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.

What was recalled

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01

Recalling firm
Baxter Healthcare Corporation
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0587-2024

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.