Drug product
0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.
D-481-2015
Product summary
- Event
- Event 69962
- Status
- Terminated
- Classification
- Class I
- Quantity
- 542,080 container bags
- Official record key
drug-enforcement:D-481-2015
Official wording
Reason: Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Code information: Lot #: P317891, P317842, Exp 05/15
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter