FDA recall D-0556-2022

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

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2022-01-26

Report date

2022-02-16

Termination date

2024-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0556-2022