Levofloxacin in 5% Dextrose Injection — Class I drug recall D-0574-2018
Terminated recall by AuroMedics Pharma LLC, reported 2018-03-07, distributed nationwide. Presence of Particulate Matter; contains visible particulate matter identified as mold.
| Recall number | D-0574-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2018-01-12 |
| Classified | 2018-03-01 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2020-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 6,072 bags |
| Reason classes | microbial contamination, specification failure |
| Pathogens | mold |
| NDC | 55150-0243, 55150-0243-46, 55150-0244, 55150-0244-47, 55150-0245, 55150-0245-52 |
| Lot numbers | CLF160003 |
| Expiration dates | 2018-05-20 |
Product
Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ---- NDC 55150-243-46
Reason for recall
Presence of Particulate Matter; contains visible particulate matter 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-0574-2018. 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.