Why it was recalled
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Product description
5% Dextrose Injection, USP, 250mL VIAFLEX 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 0338-0017-02
Lot numbers, UPCs & expiration codes
Lot #: C963413 and C963413A, 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-1209-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 24, 2015
- FDA report date
- Jul 15, 2015
- Quantity
- 402,284 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-1209-2015, 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 #: C963413 and C963413A, Exp 7/31/2016
- Postal code
- 60015-4625
- Report date
- Jul 15, 2015
- Product type
- Drugs
- Recall number
- D-1209-2015
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 402,284 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
- 5% Dextrose Injection, USP, 250mL VIAFLEX 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 0338-0017-02
- Distribution pattern
- US, Puerto Rico, and Bermuda
- Recall initiation date
- Mar 24, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 6, 2015