Why it was recalled
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Product description
Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02
Lot numbers, UPCs & expiration codes
Lot #: C964619, C964056 and C964163, Exp 7/31/2016
Where it was sold
US, Puerto Rico, and Bermuda
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-1211-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 24, 2015
- FDA report date
- Jul 15, 2015
- Quantity
- 58,932 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-1211-2015, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70926
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: C964619, C964056 and C964163, Exp 7/31/2016
- Postal code
- 60015-4625
- Report date
- Jul 15, 2015
- Product type
- Drugs
- Recall number
- D-1211-2015
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 58,932 bags
- Termination date
- Feb 7, 2017
- Reason for recall
- Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02
- Distribution pattern
- US, Puerto Rico, and Bermuda
- Recall initiation date
- Mar 24, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 6, 2015