Recall: D-1610-2014

Class I - Dangerous

Class IClassification

2014-08-07Initiated

TerminatedStatus

Baxter Healthcare Corp.Firm

Product

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.

Reason

Presence of Particulate Matter: particulate matter was found during the manufacturing process.

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.