Drug product
0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03
D-0731-201
Product summary
- Event
- Event 73235
- Status
- Terminated
- Classification
- Class II
- Quantity
- 257,364 bottles
- Official record key
drug-enforcement:D-0731-201
Official wording
Reason: PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
Code information: Lot # G120162, Exp 11/18
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
PARTICULATE MATTER