Drug product
0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.
D-0976-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 70818
- Status
- Terminated
- Classification
- Class I
- Quantity
- 9,912 VisIV flex containers
- Official record key
drug-enforcement:D-0976-2015
Official wording
Reason: Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
Code information: Lot # 45-110-C6; Exp 03/1/16
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter