Drug product
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
D-0517-2020
Product summary
- Event
- Event 84288
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22336 bags
- Official record key
drug-enforcement:D-0517-2020
Official wording
Reason: Lack of Assurance of Sterility: Product has the potential to leak.
Code information: Lot #: Y309971, Y309971A, Exp. date 6/30/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Lack of Assurance of Sterility: Product has the potential to leak.