Drug product
CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04.
D-0864-2016
Product summary
- Event
- Event 73118
- Status
- Terminated
- Classification
- Class I
- Quantity
- 7,436 bags
- Official record key
drug-enforcement:D-0864-2016
Official wording
Reason: Presence of Particulate Matter: identified as dried skin.
Code information: Lot #: P333930, Exp 05/31/2017
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter