Drug product
Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04
D-0428-2015
Product summary
- Event
- Event 70695
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7444 containers
- Official record key
drug-enforcement:D-0428-2015
Official wording
Reason: Lack of Assurance of Sterility; increased complaints received for leaks
Code information: Product code: 2B7722; Lot#: P306365, exp date: 8/31/2015
Distribution pattern: Nationwide and Singapore
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility