Drug product
0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
D-1591-2014
Product summary
- Event
- Event 68728
- Status
- Terminated
- Classification
- Class I
- Quantity
- a) 217,536 bags; b) 161,760 bags
- Official record key
drug-enforcement:D-1591-2014
Official wording
Reason: Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Code information: Lot #: a) P309187, Exp 10/14; b) P298190, Exp 08/14
Distribution pattern: Nationwide, Puerto Rico, Singapore, and Hong Kong
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter