D-0392-2015 Class I Terminated
FDA drug recall D-0392-2015 was initiated by Hospira Inc. on Jul 10, 2014 and is designated Class I. Reason for recall: Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold. The recall status is terminated (terminated Nov 23, 2015). Affected quantity: 142,644 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 25, 2015
- Initiation Date
- Jul 10, 2014
- Termination Date
- Nov 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 142,644 bags
Product Description
LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09
Reason for Recall
Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
Distribution Pattern
Nationwide
Code Information
Lot # 35-118- JT, Exp. 11/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0392-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026