D-1108-2015 Class I Terminated
FDA drug recall D-1108-2015 was initiated by Hospira Inc. on Mar 11, 2015 and is designated Class I. Reason for recall: Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold The recall status is terminated (terminated Jan 2, 2017). Affected quantity: 24,744 flexible container bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 3, 2015
- Initiation Date
- Mar 11, 2015
- Termination Date
- Jan 2, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,744 flexible container bags
Product Description
LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.
Reason for Recall
Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
Distribution Pattern
Nationwide
Code Information
Lot # 40-008-JT; Exp. 04/01/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1108-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026