FDA Drug recall D-0704-2018
Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactur…
- FDA Drug
- Class II
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class II recall of Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactur… by Auromedics Pharma, citing lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0704-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-27 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Auromedics Pharma |
| Distribution | US |
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
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Identifiers
| ndc | 55150-243-46 |
|---|---|
| ndc | 55150-244-47 |
| ndc | 55150-245-52 |
| code_info | Lot/Batch #'s: CLF160002, CLF160004, CLF160005 exp May 2018; CLF160006, CLF160007 exp June 2018; CLF170027 exp July 2019; CLF170029 exp August 2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2021-02-10 · Auromedics Pharma
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0704-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.