Drug product
Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04.
D-1158-2014
Product summary
- Event
- Event 67107
- Status
- Terminated
- Classification
- Class I
- Quantity
- 14,574 bags
- Official record key
drug-enforcement:D-1158-2014
Official wording
Reason: Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Code information: Lot#: P287045, Exp 6/2014
Distribution pattern: US Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter