FDAFDA · Food and drugs·Recall number D-1610-2014
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.
Published October 8, 2014 · Recall initiated: August 7, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DIANEAL LOW CALCIUM WITH DEXTROSE
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- Nationwide
- Lot
- Lot #: C940700, C940841, Exp 05/16
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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