Drug product
0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02
D-0957-2016
Product summary
- Event
- Event 72816
- Status
- Terminated
- Classification
- Class I
- Quantity
- 255,852 VIAFLEX Plastic Containers
- Official record key
drug-enforcement:D-0957-2016
Official wording
Reason: Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Code information: Lot # C980227; Exp. 11/16
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter