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
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Classification
Class I
Status
Terminated
Lot
Lot CPB200013, exp 9/2022
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
AuroMedics Pharma LLC — Class I Recall | MedicineWatch US