Drug recall
Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only…
FDA recall event 78932 · Class I · AuroMedics Pharma LLC
Key facts
| Event ID | 78932 |
|---|---|
| Recall numbers | D-0574-2018 |
| Recalling firm | AuroMedics Pharma LLC |
| Product type | Drugs |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Presence of Particulate Matter; contains visible particulate matter identified as mold. |
| Initiation date | Jan 12, 2018 |
| Report date | Mar 7, 2018 |
| Termination date | Apr 1, 2020 |
| City | East Windsor |
| State | NJ |
| Country | United States |
| FEI number | 3014054088 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: