D-263-2013 Class I Terminated
FDA drug recall D-263-2013 was initiated by Hospira Inc. on Oct 5, 2012 and is designated Class I. Reason for recall: Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold. The recall status is terminated (terminated Aug 21, 2015). Affected quantity: 136,224 flexible containers.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 24, 2013
- Initiation Date
- Oct 5, 2012
- Termination Date
- Aug 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 136,224 flexible containers
Product Description
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.
Reason for Recall
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Distribution Pattern
Nationwide
Code Information
Lot # :12-160-JT*, Exp 12/01/13; lot number * may be followed by 01 or 90
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-263-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026