Drug product
LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
D-1270-2020
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 85625
- Status
- Terminated
- Classification
- Class I
- Quantity
- 93,648 flexible container
- Official record key
drug-enforcement:D-1270-2020
Official wording
Reason: Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
Code information: Lot #: 07-514-FW Exp. 01-JUL-2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter