Drug product
Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04.
D-1160-2014
Product summary
- Event
- Event 67107
- Status
- Terminated
- Classification
- Class I
- Quantity
- 7,388 bags
- Official record key
drug-enforcement:D-1160-2014
Official wording
Reason: Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Code information: Lot# P285122, Exp 5/2014
Distribution pattern: US Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter