FDA-Drug2022-02-16Class I
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
AuroMedics Pharma LLC
Hazard
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Sold states
Nationwide in the US
Affected count
35,520 vials
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0556-2022Don't want to check this manually?
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