Drug recall
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile…
FDA recall event 89457 · Class I · AuroMedics Pharma LLC
Key facts
| Event ID | 89457 |
|---|---|
| Recall numbers | D-0556-2022 |
| Recalling firm | AuroMedics Pharma LLC |
| Product type | Drugs |
| Products | Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10 |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot |
| Initiation date | Jan 26, 2022 |
| Report date | Feb 16, 2022 |
| Termination date | Aug 20, 2024 |
| 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: