Drug product
LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.
D-1108-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 70700
- Status
- Terminated
- Classification
- Class I
- Quantity
- 24,744 flexible container bags
- Official record key
drug-enforcement:D-1108-2015
Official wording
Reason: Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
Code information: Lot # 40-008-JT; Exp. 04/01/16
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
particulates