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

Recall Number: D-0556-2022

Firm: AuroMedics Pharma LLC

Classification: Class I

Status: Terminated

Report Date: 20220216

Initiation Date: 20220126

Termination Date: 20240820

Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot

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