AuroMedics Pharma LLC recalls Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, D
Recalled February 16, 2022 · FDA recall D-0556-2022 · AuroMedics Pharma
Hazard
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot · FDA Class I
Units
35,520 vials
Sold at
Nationwide in the US
Description
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
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
Manufacturer(s)
AuroMedics Pharma LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →