Recall: D-0556-2022

Class I - Dangerous

Class IClassification

2022-01-26Initiated

TerminatedStatus

AuroMedics Pharma LLCFirm

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

Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot

Distribution

Nationwide in the US

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.