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.
Product description
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
Lot numbers, UPCs & expiration codes
Product Code: L5B4826, Lot #: C886820, Exp 11/14
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-831-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 24, 2013
- FDA report date
- Aug 7, 2013
- Quantity
- 39,486 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-831-2013, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 65784
- Address
- 1 Baxter Pkwy
- Code information
- Product Code: L5B4826, Lot #: C886820, Exp 11/14
- Postal code
- 60015-4625
- Report date
- Aug 7, 2013
- Product type
- Drugs
- Recall number
- D-831-2013
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 39,486 containers
- Termination date
- Jun 24, 2014
- Reason for recall
- Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 24, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 1, 2013