Drug product
0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11
D-623-2013
Product summary
- Event
- Event 65061
- Status
- Terminated
- Classification
- Class II
- Quantity
- 317,280 bags
- Official record key
drug-enforcement:D-623-2013
Official wording
Reason: Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
Code information: Lot: P293118; Exp Date: 10/13
Distribution pattern: Nationwide and Singapore
Derived failure modes
-
Labeling or packaging
Labeling Wrong Barcode; It may display wrong