Levofloxacin in 5% Dextrose Injection — Class II drug recall D-0704-2018
Terminated recall by AuroMedics Pharma LLC, reported 2018-05-09, distributed nationwide. Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer b
| Recall number | D-0704-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2018-03-27 |
| Classified | 2018-05-03 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2022-02-18 |
| Distributed | Nationwide (US) |
| Quantity | 46,824 bags |
| Reason classes | microbial contamination, sterility, packaging |
| Pathogens | mold |
| NDC | 55150-0243, 55150-0243-46, 55150-0244, 55150-0244-47, 55150-0245, 55150-0245-52 |
| Lot numbers | CLF160002, CLF160004, CLF160005, CLF160006, CLF160007, CLF170027, CLF170029 |
| Expiration dates | 2018-05-20, 2018-06-20, 2019-07-20, 2019-08-20 |
Product
Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for: AuroMedics Pharma, LLC, NDC 55150-243-46.
Reason for recall
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
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-0704-2018. 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.