Drug product
0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03
D-1583-2014
Product summary
- Event
- Event 69144
- Status
- Terminated
- Classification
- Class II
- Quantity
- 157,080 containers
- Official record key
drug-enforcement:D-1583-2014
Official wording
Reason: Lack of Assurance of Sterility; complaints of mold in the overpouch
Code information: Lot #C926642, Product Code: 2B1323N
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility