Drug product
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0553-18, Product Code 2B0043.
D-1592-2014
Product summary
- Event
- Event 68728
- Status
- Terminated
- Classification
- Class I
- Quantity
- 390,560 bags
- Official record key
drug-enforcement:D-1592-2014
Official wording
Reason: Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Code information: Lot #: P308650, Exp 10/14
Distribution pattern: Nationwide, Puerto Rico, Singapore, and Hong Kong
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter