Drug product
LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09
D-0392-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 68764
- Status
- Terminated
- Classification
- Class I
- Quantity
- 142,644 bags
- Official record key
drug-enforcement:D-0392-2015
Official wording
Reason: Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
Code information: Lot # 35-118- JT, Exp. 11/15
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
particulate matter