Drug product
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04
D-0301-2015
Product summary
- Event
- Event 69868
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,220 bags
- Official record key
drug-enforcement:D-0301-2015
Official wording
Reason: Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Code information: Product Code 2B7717 Lot # P311357, exp 12/31/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility