Drug recall D-1610-2014
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 for recall
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Lots and codes
Lot #: C940700, C940841, Exp 05/16
Recall details
- Recalling firm
- Baxter Healthcare Corp., Deerfield, IL
- Quantity
- 50,530 bags
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 7, 2014
- Terminated
- April 28, 2017
Related products
- DIANEAL Low Calcium with Dextrose – drug information
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- NDC 0941-0413 DIANEAL PD-2 with Dextrose · Dextrose Monohydrate 2.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
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- NDC 0941-0426 DIANEAL PD-2 with Dextrose · Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
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- 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