Drug product
0.9% Sodium Chloride Injection, USP, in 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 0338-0049-02
D-1208-2015
Product summary
- Event
- Event 70926
- Status
- Terminated
- Classification
- Class I
- Quantity
- 202,824 Bags
- Official record key
drug-enforcement:D-1208-2015
Official wording
Reason: Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Code information: Lot #: C965038, C965293, C963785, C963884, C963660, C964320, C964486 and C964890, Exp 7/31/2016
Distribution pattern: US, Puerto Rico, and Bermuda
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter