Recalls / Class II
Class IID-831-2013
Product
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07
- Brand name
- Dianeal Low Calcium With Dextrose
- Generic name
- Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose
- Active ingredients
- Calcium Chloride, Dextrose Monohydrate, Magnesium Chloride, Sodium Chloride, Sodium Lactate
- Route
- Intraperitoneal
- NDCs
- 0941-0409, 0941-0411, 0941-0413, 0941-0415, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424 +5 more
- FDA application
- NDA017512
- Affected lot / code info
- Product Code: L5B4826, Lot #: C886820, Exp 11/14
Why it was recalled
Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Vantive US Healthcare LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 39,486 containers
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-07-24
- FDA classified
- 2013-08-01
- Posted by FDA
- 2013-08-07
- Terminated
- 2014-06-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-831-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.