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, Product Code 2B0043, NDC 0338-0553-18.
D-1335-2015
Product summary
- Event
- Event 71749
- Status
- Terminated
- Classification
- Class I
- Quantity
- 133,600 bags
- Official record key
drug-enforcement:D-1335-2015
Official wording
Reason: Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Code information: Lot#: P327635, Exp 12/15
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter