Why it was recalled
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: C940700, C940841, Exp 05/16
Where it was sold
Nationwide
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-1610-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 7, 2014
- FDA report date
- Oct 8, 2014
- Quantity
- 50,530 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-1610-2014, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69011
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: C940700, C940841, Exp 05/16
- Postal code
- 60015-4625
- Report date
- Oct 8, 2014
- Product type
- Drugs
- Recall number
- D-1610-2014
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 50,530 bags
- Termination date
- Apr 28, 2017
- Reason for recall
- Presence of Particulate Matter: particulate matter was found during the manufacturing process.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 7, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 26, 2014