Drug product
0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, NDC 0338-0049-02.
D-0957-2017
Product summary
- Event
- Event 77678
- Status
- Terminated
- Classification
- Class II
- Quantity
- 131,904 bags
- Official record key
drug-enforcement:D-0957-2017
Official wording
Reason: Lack of Assurance of Sterility: Customer complaints for leaking bags.
Code information: Lot: Y229153, Exp 09/30/18
Distribution pattern: Nationwide in USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility