Drug product
0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04.
D-1282-2014
Product summary
- Event
- Event 67974
- Status
- Terminated
- Classification
- Class II
- Quantity
- 211,752 bottles
- Official record key
drug-enforcement:D-1282-2014
Official wording
Reason: Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Code information: Lot # Gl09272; Exp 09/16
Distribution pattern: nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter