FDA Drug recall D-0574-2018
Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics P…
- FDA Drug
- Class I
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class I recall of Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics P… by Auromedics Pharma, citing presence of Particulate Matter; contains visible particulate matter identified as mold.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0574-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-01-12 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Auromedics Pharma |
| Distribution | US |
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
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Identifiers
| ndc | 55150-243-46 |
|---|---|
| ndc | 55150-244-47 |
| ndc | 55150-245-52 |
| code_info | Lot CLF160003, exp May 2018 |
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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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0574-2018%22
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