LACTATED RINGER'S IRRIGATION — Class I drug recall D-1108-2015
Terminated recall by Hospira Inc., reported 2015-06-03, distributed nationwide. Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the pri
| Recall number | D-1108-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2015-03-11 |
| Classified | 2015-05-28 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2017-01-02 |
| Distributed | Nationwide (US) |
| Quantity | 24,744 flexible |
| Reason classes | microbial contamination, sterility, specification failure |
| Pathogens | mold |
| NDC | 00409-7828-08 |
| Lot numbers | 40-008-JT |
| Expiration dates | 2016-04-01 |
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1108-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.