Product: 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
Reason for recall: Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Recall initiated: 20220126
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated