Drug recall D-1276-2014
Product
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11
Reason for recall
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Lots and codes
Lot number: C903799, Exp 05/15
Recall details
- Recalling firm
- Baxter Healthcare Corp., Deerfield, IL
- Quantity
- 27,169 containers
- Distribution
- Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 11, 2014
- Terminated
- July 22, 2015
Related products
- DIANEAL Low Calcium with Dextrose – drug information
- NDC 0941-0415 DIANEAL PD-2 with Dextrose · Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0413 DIANEAL PD-2 with Dextrose · Dextrose Monohydrate 2.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0409 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0429 DIANEAL PD-2 with Dextrose · Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0411 DIANEAL PD-2 with Dextrose · Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0457 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 2.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0426 DIANEAL PD-2 with Dextrose · Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0487 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 2.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0490 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0459 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0484 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0424 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0433 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0430 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 2.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0427 DIANEAL PD-2 with Dextrose · Dextrose Monohydrate 2.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC