Drug product
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
D-0862-2016
Product summary
- Event
- Event 73118
- Status
- Terminated
- Classification
- Class I
- Quantity
- 273,520 bags
- Official record key
drug-enforcement:D-0862-2016
Official wording
Reason: Presence of Particulate Matter: identified as cardboard.
Code information: Lot #: P328997, Exp 01/31/2016
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter