Drug product
5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04
D-0426-2015
Product summary
- Event
- Event 70770
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48,874
- Official record key
drug-enforcement:D-0426-2015
Official wording
Reason: Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Code information: Lot #: C926899, Exp 7/31/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility